MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-08 for NEURX DPS SYSTEM 20-0035 manufactured by Synapse Biomedical, Inc..
[37748506]
Mother called to say patient died while using the diaphragm pacemaker stimulator device that she believes malfunctioned because the screen was blank. Patient was at home with mother as caregiver. Mother alleges that she was in a different room from the patient per his request, watching him on a video camera of some sort. She stated she noticed his chest wasn't rising and falling as it should be so she went into the room and found him unresponsive. Mother states that she bagged patient and called 911. He was taken to a local hospital (not our facility where we placed the device) where he was pronounced brain dead. Mother was asked to return the device but so far she has not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5418706 |
| MDR Report Key | 5418706 |
| Date Received | 2016-02-08 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-02-03 |
| Date Facility Aware | 2016-02-03 |
| Report Date | 2016-02-05 |
| Date Added to Maude | 2016-02-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DPS SYSTEM |
| Generic Name | DIAPHRAGM PACEMAKER STIMULATOR |
| Product Code | OIR |
| Date Received | 2016-02-08 |
| Model Number | 20-0035 |
| Device Expiration Date | 2016-04-01 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SYNAPSE BIOMEDICAL, INC. |
| Manufacturer Address | 300 ARTINO ST. OBERLIN OH 44074 US 44074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-02-08 |