MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-17 for SMARTMONITOR 2 4003 manufactured by Philips Respironics - Chmv.
[3569132]
Children's medical ventures (chmv) received a report from a durable medical equipment (dme) supplier stating that on (b)(6) 2013, a smartmonitor device has failed to alarm during an apnea event resulting in the pt being transported to the hospital. The current condition of the pt is unk and the device has yet to be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
[10710971]
(b)(4). 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 the limits prescribed by the physician. Pt alarms are set by the health care professional before the smartmonitor 2 is delivered to the pt. During monitoring, when the pt's breathing effort and/or heart activity are not within these set boundaries, an indicator light comes on and an alarm sounds. The dme has been contacted for additional information and the return of the device. Once the investigation into the reported issue has been concluded, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00006 |
| MDR Report Key | 3122157 |
| Report Source | 05 |
| Date Received | 2013-05-17 |
| Date of Report | 2013-04-19 |
| Date Mfgr Received | 2013-04-19 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2013-05-22 |
| 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 |
| Manufacturer Phone | 4123808804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-05-17 |
| Model Number | 4003 |
| Device Availability | N |
| 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 | 1. Hospitalization | 2013-05-17 |