MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-19 for ENVISION BLOWER KIT P136026 manufactured by Hill-rom Batesville.
[62746687]
The pressure wound was treated with dakins solution and abdominal pads. Development of pressure ulcers is multifactorial and cannot be only attributed to performance of the surface. Risk factors include protein-calorie malnutrition, microclimate (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, repositioning needs to avoid stress on the skin, and body positions need to minimize the risk of pressure on vulnerable areas. The blower connection was not properly attached causing the blower to not function as designed. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this blower in august 2016. It is unknown if the facility performed any other preventative maintenance on this blower. The technician properly connected the blower to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[62746688]
Hill-rom received a report from the account stating the patient developed a pressure ulcer on his sacrum that progressed to stage 4. The blower was located at the account. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2016-00532 |
| MDR Report Key | 6186387 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-19 |
| Date of Report | 2016-11-21 |
| Date of Event | 2016-11-21 |
| Date Mfgr Received | 2016-11-21 |
| Date Added to Maude | 2016-12-19 |
| 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 | LORI DAULTON |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENVISION BLOWER KIT |
| Generic Name | BED FLOTATION THERAPY POWERED |
| Product Code | IOQ |
| Date Received | 2016-12-19 |
| Model Number | P136026 |
| 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 | 1. Other | 2016-12-19 |