MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-22 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM - INCLUDES PATIENT 4003 manufactured by Philips Medical Systems.
[5293695]
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.
Patient Sequence No: 1, Text Type: D, B5
[12497124]
(b)(4). A f/u report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-06313 |
| MDR Report Key | 4265061 |
| Report Source | 05,06 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-09-25 |
| Date Mfgr Received | 2014-09-25 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM - INCLUDES PATIENT |
| Product Code | NPF |
| Date Received | 2014-10-22 |
| Model Number | 4003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-22 |