MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for UNKNOWN manufactured by Unknown.
[70787070]
Patient Sequence No: 1, Text Type: N, H10
[70787071]
The patient was seated in the chair (with chair alarm on). They were having incontinence issues during shift. I was sitting at computer station outside of room. I heard the patient make some abnormal sounds. I entered the room to see that he started urinating in chair. I told patient that is fine, and that i needed him to please stay in the chair while i retrieved clean linens and gown. The leg rest was up to keep legs elevated. I made it to the clean linen room when i heard the chair alarm go off i moved quickly towards the room when i heard a few bangs. When i arrived he was half laying down/ sitting up with the chair turned over. Asked if he was alright, pt. Stated he was fine. Visual inspection showed no signs of bruising or trauma. Pt. Denied hitting head. With assistance from two people we were able to get him up and moved to his bed. No identifying information is available for chair. No injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6431597 |
| MDR Report Key | 6431597 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-08 |
| Date of Event | 2016-10-22 |
| Report Date | 2017-03-08 |
| Date Reported to FDA | 2017-03-08 |
| Date Reported to Mfgr | 2017-03-08 |
| Date Added to Maude | 2017-03-24 |
| 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 | 3 |
| Brand Name | UNKNOWN |
| Generic Name | CHAIR, EXAMINATION AND TREATMENT |
| Product Code | FRK |
| Date Received | 2017-03-24 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |