MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-03 for FLEXICAIR MC3 NA manufactured by Hill-rom., A Hillen Brand Industry.
[16141943]
At 7:45am a resident was seen in bed sleeping by rn supervisor. At 8:00am na entered room to set up breakfast tray. She noted resident's head, left arm and chest to be in side rail. Resident's legs were folded underneath in a kneeling position. Na went to desk for assistance. R. N. Supervisor, charge rn 11-7 shift and two other nurses helped resident to bed. Resident was a d. N. R. Nurses were unable to obtain blood pressure and no pulse. No mottling noted. Resident noted to have indent from side rail on left chin area, left forehead and chest area under left breast. Physician was notified at 8:05am. He called coroner's office. Family notified. Facility called coroner's office for findings on 4/1/97.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 81918 |
| MDR Report Key | 81918 |
| Date Received | 1997-04-03 |
| Date of Report | 1997-03-29 |
| Date of Event | 1997-03-29 |
| Date Facility Aware | 1997-03-29 |
| Report Date | 1997-04-03 |
| Date Reported to FDA | 1997-04-03 |
| Date Reported to Mfgr | 1997-04-03 |
| Date Added to Maude | 1997-04-09 |
| 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 | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXICAIR MC3 |
| Generic Name | WOUND CARE BED |
| Product Code | INY |
| Date Received | 1997-04-03 |
| Returned To Mfg | 1997-03-29 |
| Model Number | MC3 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 81326 |
| Manufacturer | HILL-ROM., A HILLEN BRAND INDUSTRY |
| Manufacturer Address | 4349 CORPORATE RD CHARLESTON SC 29405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-04-03 |