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 2018-09-25 for P500 MRS CONTROL UNIT P005723CAP02 manufactured by Hill-rom Batesville.
[121583153]
The account stated that the mattress was not inflating properly and the patient had a pre existing wound on his right ischium that was almost healed, but has now progressed into a stage 3 wound. The patient stated that he is receiving the same daily wound dressing changes, but more frequently due to the extra leakage. A stage 3 pressure ulcer meets the criteria for a serious injury per fda definition. Development of pressure ulcers is multi-factorial and cannot be only attributed to performance of the surface. Risk factors include protein-calorie malnutrition, micro-climate (skin wetness caused by sweating or incontinence), diseases that reduce blood flow to the skin, such as arteriosclerosis, or diseases that reduce the sensation in the skin, such as paralysis or neuropathy. Position changes are key to pressure sore prevention and treatment. These changes need to be frequent, re-positioning needs to avoid stress on the skin, and body positions need to minimize the risk of pressure on vulnerable areas. The hill-rom technician evaluated the mattress and blower and found the hose connections were clogged due to nicotine build up. He also found some of the hose connections were broken and unable to connect due to the damaged sustained from the account moving the unit from room to room. The blower unit was also showing a pneumatic error 3 due to the air loss. It is necessary for the p500 to have an effective maintenance program. We recommend that you do annual preventive maintenance. Examine the air filter for cleanliness. Clean or replace as necessary. Make sure the hose, hose connectors, hose receptacles, and end covers are not damaged (no kinks, cracks, holes, broken parts, etc. ) replace or repair as necessary. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[121583154]
Hill-rom received a report from the patient stating his pre existing wound was almost healed and now it has gotten worse. The blower and mattress are located at 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 | 1824206-2018-00372 |
| MDR Report Key | 7905462 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-09-25 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2018-08-31 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2018-09-25 |
| 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 | P500 MRS CONTROL UNIT |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-09-25 |
| Model Number | P005723CAP02 |
| Device Availability | Y |
| 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 | 2018-09-25 |