MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-08-21 for TOTAL CARE FRAME P1900D003373 manufactured by Hill-rom Batesville.
[23723759]
The account purchased the bed from ((b)(6)). The reported injuries are serious in nature per fda definition. However, hill-rom was unable to determine if a malfunction took place. The customer indicated they will asses/service the bed separately. It is unknown if the facility performs preventative maintenance on their beds.
Patient Sequence No: 1, Text Type: N, H10
[23723760]
Hill-rom received a report from the account stating the mattress was not inflating properly and the patient developed a stage 4 wound on his backside. The patients wound was treated with a wound vac. The bed was located in the patients home. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2015-00835 |
| MDR Report Key | 5021908 |
| Report Source | CONSUMER |
| Date Received | 2015-08-21 |
| Date of Report | 2015-07-24 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-08-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTAL CARE FRAME |
| Generic Name | A/C POWERED ADJUSTABLE HOSPITAL BED |
| Product Code | FNK |
| Date Received | 2015-08-21 |
| Model Number | P1900D003373 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM BATESVILLE |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-21 |