MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-06 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT 4002 manufactured by Philips Medical Systems.
[5558109]
Philips healthcare received a complaint from a (b)(4) supplier detailing a smart monitor 2 infant apnea monitor stopped alarming during testing. The device was not on a patient and no harm was alleged.
Patient Sequence No: 1, Text Type: D, B5
[13126204]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[13401307]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2015-01308 |
| MDR Report Key | 4577322 |
| Report Source | 06 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-12 |
| Date Mfgr Received | 2015-02-12 |
| Date Added to Maude | 2015-03-06 |
| 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 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2015-03-06 |
| Model Number | 4002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-03-06 |