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 2018-03-19 for ENVELLA BED P0819A manufactured by Hill-rom Batesville.
[102771248]
The hill-rom technician found the staff had failed to restart the air fluidized therapy. The technician found no problem for this device. The patient's sacral wound progressed from a deep tissue injury to a stage 4. The patient was treated with low frequency ultrasounds and advanced wound care products. 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
[102771249]
Hill-rom received a report from the account stating the patient's sacrum wound worsened to a stage 4. 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 | 1824206-2018-00119 |
| MDR Report Key | 7349537 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-03-19 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2017-06-08 |
| Date Added to Maude | 2018-03-19 |
| 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 | 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 | ENVELLA BED |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2018-03-19 |
| Model Number | P0819A |
| 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 | 2018-03-19 |