Monitor, Bed Patient
General Hospital · 21 CFR 880.2400
Recent MDR events
3,238 adverse event reports on file
- Chair Alarm BeltJul 27, 2026MalfunctionTidi Products Llc2182318-2026-00081
- Chair Alarm BeltJul 27, 2026MalfunctionTidi Products Llc2182318-2026-00082
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07461
- CUBBY BEDSJul 21, 2026MalfunctionSensory Medical Inc.3016541541-2026-00062
- CUBBY BEDSJul 21, 2026MalfunctionSensory Medical Inc.3016541541-2026-00061
- SITTER ON CUE PROJul 20, 2026MalfunctionTidi Products Llc2182318-2026-00073
- CUBBY BEDSJul 17, 2026MalfunctionSensory Medical Inc.3016541541-2026-00057
- CHAIR ALARM BELTJul 17, 2026MalfunctionTidi Products Llc2182318-2026-00070
- MEDLINEJul 8, 2026MalfunctionMedline Industried Lp1417592-2026-04662
- MEDLINEJul 8, 2026MalfunctionMedline Industried Lp1417592-2026-04661
Event type breakdown
Recalls
32 recall events for this product code
- Richard Wolf Medical Instruments Corp.TerminatedMar 3, 2015
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.
Z-1240-2015 · View FDA record ↗ - Curbell Medical, Inc.TerminatedAug 26, 2014
CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Be
The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.
Z-2554-2014 · View FDA record ↗ - RF Technologies, Inc.TerminatedJun 26, 2013
Code Alert Advanced 4-Way Care Solution, CA520 System,
RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error, the alarm may not be transmitted to the system server immediately.
Z-1597-2013 · View FDA record ↗ - Intel-GE Care Innovations LLCTerminatedFeb 23, 2013
QuietCare-Networked product, Facility Server/model: QC101601;
Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered.
Z-0877-2013 · View FDA record ↗ - Stanley Security Solutions, Inc.TerminatedSep 28, 2012
Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE.
The monitor may fail to sound an alarm
Z-2488-2012 · View FDA record ↗ - Stanley Security Solutions, Inc.TerminatedSep 28, 2012
Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE.
The monitor may fail to sound an alarm
Z-2489-2012 · View FDA record ↗ - Stanley Security Solutions, Inc.TerminatedSep 28, 2012
Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE.
The monitor may fail to sound an alarm
Z-2490-2012 · View FDA record ↗ - Stanley Security Solutions, Inc.TerminatedSep 28, 2012
Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE.
The monitor may fail to sound an alarm
Z-2491-2012 · View FDA record ↗ - Stanley Security Solutions, Inc.TerminatedSep 28, 2012
Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE.
The monitor may fail to sound an alarm
Z-2492-2012 · View FDA record ↗ - Stanley Security Solutions, Inc.TerminatedApr 28, 2012
Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE.
Connection between the call cord and the receptacle may not make a correct connection resulting in a continuous or intermittent (false) signal to the nurse call system
Z-1476-2012 · View FDA record ↗
Registered firms
116 firms currently registered for this product code
Tidi Products, Llc
NEENAH, WI, US
Masimo Corporation
Irvine, CA, US
P Bhogilal Pvt Ltd
Kolkata West Bengal, IN
J Sterling Industries Llc
Kalamazoo, MI, US
Eastek Mexico Holdings Llc
Fresnillo Zacatecas, MX
Zhongshan Saxin Electric Heating Technology Co., Ltd.
Zhongshan Guangdong, CN
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
Masimo Corporation
Irvine, CA, US
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Cross Innovations Llc
Cheyenne, WY, US
Caspar Ai
San Carlos, CA, US
Curbell Medical Products, Inc.
ORCHARD PARK, NY, US
Dictum Health, Inc.
Malibu, CA, US
O&m Halyard, Inc.
Alpharetta, GA, US
Foshan Fuzikon Medical Technology Co.ltd
Foshan Guangdong, CN
Xiamen Sheep Anti Fatigue Mat Co Ltd
Xiamen City Fujian, CN
210 Innovations, Llc
Groton, CT, US
Sibel Health Inc.
Chicago, IL, US
United Poly Engineering Pvt. Ltd.
NEW DELHI, IN
Parasol Medical
Buffalo Grove, IL, US
Cyient Dlm Limited
HYDERABAD Telangana, IN
Securitas Healthcare Llc
LINCOLN, NE, US
Masimo Corporation
Irvine, CA, US
510(k) clearances
31 clearances for this product code
- Leaf Healthcare, Inc.Nov 10, 2014
K141877 · LEAF PATIENT MONITORING SYSTEM
- Intel-Ge Care Innovations, LLCOct 8, 2013
K131585 · INTEL-GE CARE INNOVATIONS QUIETCARE
- Centauri Medical, Inc.Aug 15, 2013
K130752 · DYNASENSE SYSTEM
- Wireless Medcare, LLCJul 15, 2010
K101109 · VIVATRAK
- Aframe Digital, Inc.Apr 24, 2009
K090138 · MOBILECARE MONITOR, MODEL 2100
- Ultimate Development Corp.Dec 23, 1994
K942770 · ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR
- Micro-Tech Medical, Inc.Nov 2, 1994
K943481 · INFORMER PLUS
- Hill EngineeringSep 22, 1994
K933552 · PM-PAGER