MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-09-12 for CLINITRON RITEHITE C-8 ASSY P0800010019 manufactured by Hill-rom Batesville.
[85859747]
The hill-rom technician found there were too many beads and the beads needed to be decontaminated. The technician swapped the bed and decontaminated the beads to resolve the issue. The patient had a stage 3 sacrococcygeal wound that progressed to unstageable. The patient is being treated with dakin's solution. 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. Per the hill-rom user manual, poor fluidization; if fluidization is sluggish or uneven, notify your hill-rom representative. Fluidization is affected by the following: room temperature, humidity, the amount of materials, such as fluid, cells or cellular debris, which has escaped from the blood vessels and has been deposited in tissues or on tissue surfaces, restricted air circulation from blankets on the bed. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2017. It is unknown if the facility performed any other preventative maintenance on this bed. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[85859748]
Hill-rom received a report from the account stating the bed was not fluidizing and the patient's stage 3 wound progressed to unstageable. The bed was located at the account. There was a patient/user injury reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2017-00382 |
| MDR Report Key | 6859468 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-09-12 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-08-28 |
| Device Manufacturer Date | 2001-09-28 |
| Date Added to Maude | 2017-09-12 |
| 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 | 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 | CLINITRON RITEHITE C-8 ASSY |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2017-09-12 |
| Model Number | P0800010019 |
| 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 | 2017-09-12 |