MalfunctionNPF
SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM - INCLUDES PATIENT
Received Oct 22, 2014
Report 1218950-2014-06313 · MDR key 4265061
Device
Manufacturer
Philips Medical SystemsModel number
4003Product problems
- Device Alarm System
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PHILIPS HEALTHCARE RECEIVED A COMPLAINT FROM SENTARA RESPIRATORY & MEDICAL STATING THAT AN INFANT APNEA MONITOR FAILED TO ALARM WHILE PERFORMING CHECKOUT. THERE WAS NO REPORTED PT IMPACT. THE SMARTMONITOR 2 DEVICE IS DESIGNED TO MONITOR RESPIRATION, AND HEART RATE. UPON DETECTION OF ABNORMAL EVENTS. SMARTMONITOR 2 ALERTS THE CAREGIVER VIA BOTH VISUAL AND AUDIBLE ALARMS AND RECORDS THE INFO FOR SUBSEQUENT CLINICAL REVIEW.
Additional Manufacturer Narrative
(B)(4). A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.