MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-07 for COMBI TILT W/HEAD AND FOOT REST 201941314-HF manufactured by Brako.
[69328419]
Outcome of investigation is pending. A final report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[69328420]
A patient was seated in a combi chair. As the chair was being repositioned the right front caster (wheel) fell off. The patient fell out off the chair and was injured. They were taken to the hospital, treated for their injuries, and released the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802293-2017-00087 |
| MDR Report Key | 6386076 |
| Date Received | 2017-03-07 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-01-22 |
| Date Facility Aware | 2017-02-07 |
| Date Added to Maude | 2017-03-07 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | COMBI TILT W/HEAD AND FOOT REST |
| Generic Name | COMBI TILT |
| Product Code | INM |
| Date Received | 2017-03-07 |
| Model Number | 201941314-HF |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAKO |
| Manufacturer Address | RASHTANSKI PAT BB VELES140 MK VELES 1400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-03-07 |