MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-28 for THERAFLO 2001002 manufactured by Tridien Medical.
[73479089]
While receiving personal care the patient was turned on her side while pulling on the upper half side rail to assist. The lower half side rail was down. As she was turning the air mattress deflated so that the patient? S lower extremities slid out of the bottom side of the bed on to the floor. The aide went to the patient and helped her to slowly slide on to floor; and went for help. She was transported to the hospital where she underwent examination and it was determined that she had bilateral fractures of the femur. She revoked the hospice benefit to receive aggressive therapy. When it was determined that she was not a candidate for surgery she was readmitted to the hospice benefit and transferred to the hospice inpatient unit. She died after being at the unit for three days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6512549 |
| MDR Report Key | 6512549 |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-03-19 |
| Date Facility Aware | 2017-03-19 |
| Report Date | 2017-03-28 |
| Date Reported to FDA | 2017-03-28 |
| Date Reported to Mfgr | 2017-03-28 |
| Date Added to Maude | 2017-04-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERAFLO |
| Generic Name | LOW AIR-LOSS MATTRESS |
| Product Code | IOQ |
| Date Received | 2017-03-28 |
| Model Number | 2001002 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIDIEN MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-03-28 |