MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-23 for SMARTMONITOR 2 PROFESSIONAL SERIES 1030271 manufactured by Philips Respironics - Chmv.
[3808677]
Children's medical ventures (chmv) received a report from a durable medical equipment (dme) supplier stating that an infant apnea monitor was not picking up heart rate and respiratory rate. The product was reportedly in use at the time of the reported event. There is no allegation of pt harm. However, it is not known if the device alarmed at the time of the reported failure to notify the caregiver of a potential event. The dme has been contacted for additional information and stated that the device was put through and passed the device checkout verification procedure prior to being put into pt use but that no additional information was available at this time in relation to whether or not the device alarmed at the time of the reported event. This report is being filed due to the fact that it is unknown whether or not the unit alarmed appropriately for the reported event.
Patient Sequence No: 1, Text Type: D, B5
[11198612]
(b)(4). Additional information for 510(k): k061256. The complaint issue alleged by the customer was not able to be confirmed because the device has not been returned to the manufacturer for evaluation. Smartmonitor2 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 alarm limits are set by the health care professional before the smartmonitor2 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. A follow-up report will be filed detailing the investigation conclusions once the device has been returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00011 |
| MDR Report Key | 3349136 |
| Report Source | 05 |
| Date Received | 2013-08-23 |
| Date Mfgr Received | 2013-07-24 |
| Date Added to Maude | 2013-11-20 |
| 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 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 PROFESSIONAL SERIES |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-08-23 |
| Model Number | 1030271 |
| 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 | 2013-08-23 |