MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-07-02 for SMARTMONITOR 2 4002 manufactured by Philips Respironics - Chmv.
[3478487]
Children's medical ventures (chmv) received a complaint report from a durable medical equipment (dme) supplier stating that a smartmonitor device was found to have no audible alarm during check-out procedural testing. The device was reportedly not in pt use at the time, there was no death or serious injury associated with the alleged complaint condition.
Patient Sequence No: 1, Text Type: D, B5
[11023960]
(b)(4). The mfr received the device for eval and the customer complaint was confirmed. The device was found to have no audible alar. However, the design incorporated led visual indicator functioned to spec. The unit alarmed to spec with the test alarm module. The cause of the failure was isolated to the alarm module. The alarm module was forwarded to supplier quality engineering for further investigation. Smartmonitor 2 is designed to monitor and record pt's breathing (respiration), heart (cardiac) activity. The monitor alerts you if any of these activities exceeds and/or heart activity are not within these set boundaries, an indicator light comes on and an alarm sounds. A supplier corrective action has been initiated with the mfr of the alarm module to investigate the recorded failure. Once the investigation has been completed, a f/u report will be filed on detail the conclusions reached during the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00009 |
| MDR Report Key | 3209568 |
| Report Source | 05 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-06-06 |
| Date Mfgr Received | 2013-06-06 |
| Date Added to Maude | 2013-09-25 |
| 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 | CHRIS FERGUSON |
| Manufacturer Street | 191 WYNGATE DR |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-07-02 |
| Returned To Mfg | 2013-06-12 |
| Model Number | 4002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-07-02 |