MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-08-09 for 300 WOUND SURFACE P4937EAS1 manufactured by Hill-rom Batesville.
[82158463]
The hill-rom technician evaluated the bed and found the snaps on the center cushions had become unsnapped. The technician reconnected the snaps on the center cushions to resolve the issue. The patient is being treated with mupirocin ointment. The pressure sore is nearly healed and the patient will be seeing the wound care doctor again next week. Per the hill-rom service manual, during the initial inflation of mattress with bolster, the installer should adjust the bolsters into the proper location on the surface. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed. It is unknown if the facility performs preventative maintenance on their beds. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[82158464]
Hill-rom received a report from the account stating the patient had skin breakdown due to the bladders shifting inside the mattress. The bed was located at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2017-00335 |
| MDR Report Key | 6777202 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-08-09 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2015-11-12 |
| Date Added to Maude | 2017-08-09 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ERIN PADGETT |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 300 WOUND SURFACE |
| Generic Name | BED FLOTATION THERAPY POWERED |
| Product Code | IOQ |
| Date Received | 2017-08-09 |
| Model Number | P4937EAS1 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-09 |