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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE CORPORATION; CHAIR, ADJUSTABLE, MECHANICAL
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INVACARE CORPORATION; CHAIR, ADJUSTABLE, MECHANICAL Back to Search Results
Device Problems Bent (1059); Folded (2630)
Patient Problem Fall (1848)
Event Date 07/03/2017
Event Type  malfunction  
Event Description
Rn came in to find patient laying supine on bathroom floor, having fallen from shower chair after getting cleaned up.Back left shower chair leg was completely bent and folded under chair, causing pt to fall from it.Pt neuro intact, alert and answering questions appropriately.Pt denies striking head and loss of consciousness (loc).After brief assessment, rn assisted pt safely to commode where a set of vitals were taken, all within normal limits.Pt denying any acute symptoms at this time, denying pain/discomfort from fall.Pt safely back in bed with non skid footwear on, brakes engaged, and call bell within reach.Will continue to monitor.
 
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Type of Device
CHAIR, ADJUSTABLE, MECHANICAL
Manufacturer (Section D)
INVACARE CORPORATION
39400 taylor pkwy
north ridgeville OH 44035
MDR Report Key6770630
MDR Text Key81946140
Report Number6770630
Device Sequence Number1
Product Code INN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 07/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Other Device ID NumberPW140101
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/05/2017
Event Location Hospital
Date Report to Manufacturer07/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Other;
Patient Age69 YR
Patient Weight100
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