Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Anesthesiology · 21 CFR 868.2500
Recent MDR events
16 adverse event reports on file
- DIGITAL MONITORING SYSTEMApr 19, 2022InjurySentec Ag14140827
- PHILIPS TC02 MODULEJun 22, 2010DeathPhilips Medical Systems9610816-2010-00213
- PHILIPS TC02 MODULEJun 22, 2010DeathPhilips Medical Systems9610816-2010-00214
- TCMFeb 26, 2010InjuryRadiometer Medical Aps1523456-2010-00002
- TCMNov 28, 2007InjuryRadiometer Medical Aps3002807968-2007-00015
- TCMApr 13, 2007InjuryRadiometer Medical Aps3002807968-2007-00004
- TC MONITORSep 15, 2005MalfunctionRadiometer Medical Aps3002807968-2004-00020
- TC MONITORFeb 9, 2005MalfunctionRadiometer Medical Aps3002807968-2005-00001
- HPMar 10, 1999InjuryHewlett-packard Co. Medical Products GroupMW1015914
- TCM3 TINA MONITORJan 9, 1998InjuryRadiometer America Inc.148204
Event type breakdown
Recalls
3 recall events for this product code
- Radiometer America IncTerminatedAug 31, 2006
D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations
Z-1436-06 · View FDA record ↗ - Radiometer America IncTerminatedAug 30, 2006
TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)
Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped.
Z-1437-06 · View FDA record ↗ - Radiometer America IncTerminatedAug 29, 2006
TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.
Z-1453-06 · View FDA record ↗
Registered firms
50 firms currently registered for this product code
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Philips North America Llc
Export, PA, US
Philips North America Llc
Murrysville, PA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Radiometer Solutions Sp. Z O.o.
Stargard Zachodniopomorskie, PL
Radiometer Medical Aps
BROENSHOEJ Hovedstaden, DK
Dhl Supply Chain (netherlands) B.v.
Beringe Limburg, NL
Draeger Medical Systems, Inc.
ANDOVER, MA, US
Sentec Ag
THERWIL Basel-Landschaft, CH
Boyd Corporation Gmbh
Syke Lower Saxony, DE
Radiometer Sp. Z O.o
Stargard Zachodniopomorskie, PL
Sentec, Inc.
Lincoln, RI, US
Pulsion Medical Systems Se
Aschheim, DE
510(k) clearances
47 clearances for this product code
- Linde Medical Sensors AGMay 4, 2001
K003943 · MICROGAS 7650 TRANSCUTANEOUS MONITOR
- Linde Medical Sensors AGMay 21, 1999
K991644 · MICROGAS 7650 TRANSCUTANEOUS MONITOR
- Siemens Medical Solutions USA, Inc.Aug 12, 1998
K980287 · SIEMENS SC9000/SC9015 TCP02/C02 MODULE
- Air-Shields, Inc.Jan 17, 1996
K924709 · SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
- Air-Shields Vickers, Inc.Feb 21, 1995
K924679 · OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
- Hewlett-Packard Co.Jul 29, 1993
K925910 · HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
- Mennen Medical, Inc.Jul 14, 1989
K893133 · HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
- Novametrix Medical Systems, Inc.May 27, 1987
K870805 · MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR