MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-12 for HOSPITAL BED manufactured by .
[64901126]
Patient was in his resident, around 9am wife found him between mattress and railing of hospital bed unresponsive. Wife called caretaker for help. Caretaker performed cpr while wife called 911; 911 arrived and continued performing cpr but could not resuscitate patient. Patient was pronounced dead at 9:40am. Law enforcement called investigational officer who then came to the deceased residence. Investigational officer saw red abrasion on the deceased neck. The deceased pt was then transferred to the medical examiner office. An autopsy was done and it was ruled pt died of positional asphyxia due to head and neck been compressed between metal railing and mattress of the hospital bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067192 |
| MDR Report Key | 6249039 |
| Date Received | 2017-01-12 |
| Date of Report | 2017-01-12 |
| Date of Event | 2016-12-20 |
| Date Added to Maude | 2017-01-13 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | HOSPITAL BED |
| Generic Name | BED |
| Product Code | FNJ |
| Date Received | 2017-01-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-01-12 |