MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-20 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM 4003 manufactured by Philips Medical Systems.
[5358067]
Philips healthcare has received a device from a durable medical equipment (dme) supplier requesting preventative maintenance. There was no complaint allegation against this device; however during the evaluation the manufactures service technician discovered a faulty alarm module. Although the device display provides visual indicators of alarms occurring, the device labeling does not dictate that the displayed data be continuously monitored by the user. In the presence of life-threatening events when no sound is audible, and no user is continuously monitoring the display, serious injury and/or death can occur. The alarm module has been sent to the supplier for root cause evaluation. Based on a complete review of the complaint allegation, philips healthcare has determined that the reported issue requires further investigation. Once additional information is received, a follow-up additional information report will be filed to detail the findings and the need for any possible further action.
Patient Sequence No: 1, Text Type: D, B5
[12810907]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[13299554]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2015-00934 |
| MDR Report Key | 4531782 |
| Report Source | 06 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-01-26 |
| Date Mfgr Received | 2015-01-26 |
| Device Manufacturer Date | 2013-06-24 |
| Date Added to Maude | 2015-03-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MRS. WENDY CHADBOURNE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| 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 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2015-02-20 |
| Returned To Mfg | 2015-02-02 |
| Model Number | 4003 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-20 |