MAUDE Adverse Event Report: UNKNOWN UNKNOWN; CHAIR, EXAMINATION AND TREATMENT

Device Problems Component Falling (1105); Device Displays Incorrect Message (2591)

Patient Problem Fall (1848)

Event Date 10/22/2016

Event Type  malfunction  

Event Description

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.

• Brand Name: UNKNOWN
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6431597
• MDR Text Key: 70787071
• Report Number: 6431597
• Device Sequence Number: 1
• Product Code: FRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR