MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-16 for SMARTMONITOR 2 WITH PCMCIA CARD 4002 manufactured by Philips Respironics - Chmv.
[20978668]
Philips healthcare received a report from a durable medical equipment (dme) supplier stating that an infant apnea monitor stopped alarming during testing. The device was not on a pt at this time. The date of the alleged event was on (b)(6) 2014. The dme stated that the unit is beeping and stopped beeping when it should not have. The device was received and evaluated on 09/10/2014 and the mfr's service technician was able to confirm the customer's complaint issue. The alarm pca will be sent for root cause investigation. 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
[21376879]
Pr#: (b)(4). A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-07779 |
| MDR Report Key | 4369848 |
| Report Source | 06 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-08-21 |
| Date Mfgr Received | 2014-08-21 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2015-01-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RUSTY KELLY |
| Manufacturer Street | 1250 RESEARCH PARKWAY |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer Phone | 4074556166 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 WITH PCMCIA CARD |
| Product Code | NPF |
| Date Received | 2014-09-16 |
| Model Number | 4002 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS - CHMV |
| Manufacturer Address | 191 WYNGATE DR. MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-16 |