MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-02-05 for SMART MONITOR 2 4003 manufactured by Respironics Inc..
[1323356]
The mfr was notified by a durable medical equipment supplier (dme) of an infant death that occurred while an apnea monitor was in the home. The father of the infant reported the apnea monitor was in use at the time of death ((b) (6) 2009 at 7:43 am) and alleged it did not annunciate an alarm. The apnea monitor was in the custody of the county coroner until jan 5, 2010. The dme returned the apnea monitor to the mfr for eval. The mfr was unable to confirm the report that the apnea monitor was in use at the time of death, or that the apnea monitor had failed to audibly alarm. The apnea monitor was visually examined and tested by the mfr using a simulator in accordance with the smart monitor 2 checkout procedure manual ((b) (4)). The apnea monitor detected and alarmed appropriately for simulated events and passed all required testing.
Patient Sequence No: 1, Text Type: D, B5
[8429820]
The apnea monitor's memory data was downloaded and analyzed by trained associates. The downloaded memory revealed the apnea monitor was turned off at 6:14:49 am on (b) (6) 2009 and was not turned on again until (b) (6) 2010 at 2:02:22 pm at which time the device had been returned by the coroner to the dme for memory download. The memory data also showed the apnea monitor recorded eight equipment events that triggered an audible alarm prior to being turned off on (b) (6) 2009. The data from the apnea monitor's download indicates that the device was not turned on by the caregiver and did not record any use during (b) (6) 2009, the date of the adverse event. Based on all available info, the mfr believes that the apnea monitor associated with this report was not in use at the time of death and, further, that the device operated as designed. Therefore, the mfr concludes that no further action is appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2010-00006 |
| MDR Report Key | 1600682 |
| Report Source | 05 |
| Date Received | 2010-02-05 |
| Date of Report | 2010-01-06 |
| Date of Event | 2009-12-29 |
| Date Mfgr Received | 2010-01-06 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2010-02-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHERINE DEPADUA |
| Manufacturer Street | 1740 GOLDEN MILE HIGHWAY |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 7243877770 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2010-02-05 |
| Returned To Mfg | 2010-01-13 |
| Model Number | 4003 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC. |
| Manufacturer Address | MURRYSVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-02-05 |