MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-11-16 for SMART MONITOR 970SE manufactured by Phillips Respironics, Inc..
[2963373]
A durable medical equipment (dme) supplier reported an alarm failure associated with a smart monitor 970se infant apnea device. The device was not in use at the time of the reported failure, there is no pt harm. The failure was recorded during the functional self-testing of the device.
Patient Sequence No: 1, Text Type: D, B5
[10259662]
(b)(4). Smart monitor 970se infant apnea device has been obsolete since september of 2005. The home operator's manual instructs the operator to perform the functional self-test at least once a week, when a lead wire is changed or when the pt cable is changed. The functional self-test is a user-performed test to verify smart monitor, pt cable, and lead wires are functioning properly. The home operator's manual also cautions the user that the smart monitor's lights and alarms should behave as described in the self-test. If they don't, contact your dealer. The customer was informed by letter of the products obsolesce and that the device would not be repaired. Additionally, the letter instructs the customer to return any devices associated with pt harm or alarm failure. The customer has chosen not to return the device. During f/u correspondence, an additional request was made to have the device returned for failure investigation. No equipment has been returned for eval. The customer's complaint allegation has not been substantiated. Qa has determined that all necessary replies to the customer have been completed and are documented in the complaint record. Based on the available info it is concluded that no further investigation into the alleged complaint can take place. If the device is returned for investigation, a f/u report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2012-00023 |
| MDR Report Key | 2857541 |
| Report Source | 99 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-10-16 |
| Date Mfgr Received | 2012-10-16 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2013-02-25 |
| 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 DRIVE |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 4123808804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 970SE |
| Generic Name | APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2012-11-16 |
| Model Number | 970SE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILLIPS RESPIRONICS, INC. |
| Manufacturer Address | MONROEVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-16 |