MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-20 for SMARTMONITOR 2 4002 manufactured by Childrens Medical Ventures , Philips Healthcare.
[3317180]
Children's medical ventures (chmv) received a report from a durable medical equipment (dme) supplier of a smartmonitor 2 infant apnea monitor alarm failure. The dme stated that the device was not in use at the time of the recorded failure and there is no allegation of harm.
Patient Sequence No: 1, Text Type: D, B5
[10652667]
Pr#: (b)(4). Chmv received the device for eval and the complaint allegation was confirmed. When the device was initially powered on there was no audible alarm. Additionally, no audible alarm was recorded during the self-test. However, the led visual indicators were indicating that the programed alarm limits had been exceeded and that the audible alarm should have been sounding. The alarm module was replaced with a test module and the device was found to alarm to specification. The original alarm module was then re-installed and the device was again found to alarm to specification. It was determined that the device had experienced an intermittent failure. A formal investigation has been initiated to determine the root cause of the recorded issue. 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 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 formal investigation has been initiated to determine the root cause of the recorded issue and a f/u report will be submitted once the product investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00003 |
| MDR Report Key | 3021092 |
| Report Source | 05 |
| Date Received | 2013-03-20 |
| Date of Report | 2013-02-18 |
| Date Mfgr Received | 2013-02-18 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-05-21 |
| 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 DRIVE |
| Manufacturer City | MONROEVILLE PA 151460000 |
| Manufacturer Country | US |
| Manufacturer Postal | 151460000 |
| Manufacturer Phone | 4123808804 |
| 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 | 2013-03-20 |
| Returned To Mfg | 2013-02-25 |
| Model Number | 4002 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHILDRENS MEDICAL VENTURES , PHILIPS HEALTHCARE |
| Manufacturer Address | 191 WYNGATE DRIVE MONROEVILLE PA 15146000 US 15146 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-20 |