MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for GENDRON SENTINEL II 3875 manufactured by Gendron Inc..
[104152073]
The pt was trached, on a ventilator. The therapist was reaching over the bed rails laying partially supine and was attempting "sit to stand". The bed, which was previously locked, starting rolling backwards. The patient required a "controlled decent to the floor". The bed was accessed and it was noted that the unlocking mechanism is on the side of the bed near the mechanism to raiser the head of the bed. It is surmised that the therapist accidently leaned into the panel while working with the patient and unlocked the bed wheels.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076256 |
| MDR Report Key | 7388100 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-14 |
| Date Added to Maude | 2018-04-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | GENDRON SENTINEL II |
| Generic Name | BARIATRIC HIGH LOW BED |
| Product Code | OSI |
| Date Received | 2018-03-30 |
| Model Number | 3875 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDRON INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-30 |