MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for EXCEL CARE manufactured by Hill-rom, Inc..
[70338494]
Patient Sequence No: 1, Text Type: N, H10
[70338495]
Near miss: while assisting patient to stand from bed, the patient pushed against the bed with all her weight and brake lock failed. The side bar also became dislodged. Rn was able to prevent patient from falling.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 6416865 |
MDR Report Key | 6416865 |
Date Received | 2017-03-20 |
Date of Report | 2017-03-07 |
Date of Event | 2017-03-04 |
Report Date | 2017-03-07 |
Date Reported to FDA | 2017-03-07 |
Date Reported to Mfgr | 2017-03-07 |
Date Added to Maude | 2017-03-20 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
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 | 3 |
Brand Name | EXCEL CARE |
Generic Name | BARIATRIC BED |
Product Code | OSI |
Date Received | 2017-03-20 |
Device Availability | * |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | HILL-ROM, INC. |
Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-03-20 |