MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-04 for OPTIFLEX USD437014S * manufactured by Chattanooga Group Inc..
[17719564]
Transferred from ortho floor after total knee surgery to icu due to respiratory complications. Staff in icu continued using the cpm (continuous passive motion) several times most of the night which precluded being able to reposition patient off of coccyx, resulting in stage iv decubitus ulcer. ====================== health professional's impression======================see above--it forced us to keep her on her back while in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1901236 |
| MDR Report Key | 1901236 |
| Date Received | 2010-11-04 |
| Date of Report | 2010-11-04 |
| Date of Event | 2010-10-01 |
| Report Date | 2010-11-04 |
| Date Reported to FDA | 2010-11-04 |
| Date Added to Maude | 2010-11-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLEX |
| Generic Name | CPM--CONTINUOUS PASSIVE MOTION |
| Product Code | BXB |
| Date Received | 2010-11-04 |
| Model Number | USD437014S |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP INC. |
| Manufacturer Address | 6607 MOUNTAIN VIEW RD. COLLEGE DALE TN 37363 US 37363 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-11-04 |