MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-25 for SMARTMONITOR 2 4003 manufactured by Philips Respironics - Chmv.
[4041081]
(b)(6) received a report from a durable medical equipment (dme) supplier stating that an infant apnea monitor experienced an error 0001. No resulting effect on a pt or potential user has been reported. The device was reportedly in use at the time of the reported event. However, it is known if the device alarmed appropriately for the reported failure. The dme has been contacted for additional information and to have the device in question returned for evaluation. However, neither the request for additional information nor the device has been returned. No additional information is available at this time. The alleged failure is being reported due to the fact that it is unk whether or not the unit alarmed appropriately for the reported event.
Patient Sequence No: 1, Text Type: D, B5
[11362141]
(b)(4). 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. The reported error code 0001 occurs when no battery is present at the time the smartmonitor device is powered on. The user manual states the following user/owner responsibilities. The respironics monitor and accessories are designed to work as described in the operator's manual. The user(s) of the equipment should not use parts that have failed, exhibit excessive wear, are contaminated, or otherwise ineffective. The monitor and its accessories should not be modified. Smartmonitor 2 is designed to monitor and record pt's breathing (respiration), heart(cardiac) activity. The monitor, 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. Based on a complete review of the complaint allegation, (b)(6) has no reason to believe the device in question did not perform to specification; effectively notifying the caregiver of a potential event. It is determined that no further investigation into the alleged complaint issue is appropriate at this time. However, if the device is returned for investigation and it is concluded that a malfunction outside of the design specifications took place, a follow-up, additional information report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00018 |
| MDR Report Key | 3492425 |
| Report Source | 05 |
| Date Received | 2013-10-25 |
| Date of Report | 2013-09-25 |
| Date Mfgr Received | 2013-09-25 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2014-01-28 |
| 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 | 2013-10-25 |
| Model Number | 4003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-10-25 |