MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for CECONOMY FOAM MATTRESS 5180 manufactured by Invacare Corp..
[69301633]
(b)(6) spouse reported that, at approximately 7:00 am on (b)(6) 2017, she entered the bedroom and found (b)(6) wedged between the hospital bed and the wall. Spouse called 911 and (b)(6) was pronounced dead at 7:44 am by the (b)(6) police department. (b)(6) was notified by the police officer at the scene. (b)(6) staff was immediately dispatched to the home. Specific information regarding the position of the body was not provided to (b)(6) staff by the official personnel on the scene. (b)(6) body was removed from the home by the (b)(6) medical examiner's office, where cause of death was determined to be "positional mechanical asphyxia due to entrapment confinement. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6377286 |
| MDR Report Key | 6377286 |
| Date Received | 2017-02-17 |
| Date Facility Aware | 2017-02-06 |
| Report Date | 2017-02-10 |
| Date Reported to FDA | 2017-02-13 |
| Date Reported to Mfgr | 2017-02-13 |
| Date Added to Maude | 2017-03-03 |
| 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 | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | CECONOMY FOAM MATTRESS |
| Generic Name | GEO MATTRESS |
| Product Code | FNJ |
| Date Received | 2017-02-17 |
| Model Number | 5180 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORP. |
| Manufacturer Address | ELYRIA OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-17 |