MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-02-23 for SMART MONITOR 970SE manufactured by Philips Respironics, Inc..
[2388170]
A durable medical equipment (dme) supplier reported that an infant passed away while using a smart monitor 970se infant apnea device. It was reported that "the child had been to the doctor and upon returning home when the parents went to take the child out of the car, they noticed the child appeared lifeless. " the exact date of the pt death is not known at this time and conflicting reports as to whether or not the pt was on the unit at the time of the reported incident have been received. The pt download and the device were returned to the manufacturer for eval. The manufacturer is currently investigating the details into the reported event. A follow-up report will be filed when the investigation is complete.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007056120-2012-00004 |
| MDR Report Key | 2472034 |
| Report Source | 05 |
| Date Received | 2012-02-23 |
| Date of Report | 2012-01-25 |
| Date of Event | 2012-01-25 |
| Date Mfgr Received | 2012-01-25 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2012-02-29 |
| 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 | RICH LORDO, DIR ENGINEERING |
| Manufacturer Street | 191 WYNGATE DRIVE |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 4123808826 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 970SE |
| Generic Name | APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2012-02-23 |
| Returned To Mfg | 2012-02-03 |
| Model Number | 970SE |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS, INC. |
| Manufacturer Address | MONROEVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-02-23 |