3 POSITION RECLINER-BASIC BLUE RIDGE 9153641336 IH6074A/IH61

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-10 for 3 POSITION RECLINER-BASIC BLUE RIDGE 9153641336 IH6074A/IH61 manufactured by Goodbaby.

Event Text Entries

[56928643] Hme manager states the aid was trying to bring the chair to an upright position and it would not come back up. Hme manager states the aid forced it back up. It appeared to be really hard to close and the staff had to slam it down and her foot may have gotten caught while doing this. The facility nurse stated that the push rail on the back of the geri-chair, when lifted, you have to push on it and that it doesn't close with ease. Hme manager states that it was the next morning approximately that there was a (b)(6) staff member who noticed the patient's leg swollen and bruised and that it when it was checked out by er staff and determined to be a fracture. An x-ray was obtained and confirmed a mildly displaced spiral acute fracture of the distal third of the tibia and acute oblique fracture of the distal third of the fibula with mild angulation at the fracture site. Patient was transported by ambulance to the hospital to obtain a cast to lower left leg and then transported back to long term care facility. Hme manager states there were no witnesses to the incident. Hme manager states they quarantined the chair at their facility and tested it and there are no issues with reclining and bringing the unit upright and that she took video of someone testing it and he could literally recline/decline the chair with a couple of fingers. Hme manager states there is no binding or resistance when doing so. Hme manager states she believes the reason the aid couldn't bring the chair upright was because the patient's foot was caught in the chair footrest. Hme manager states they cannot release the chair to invacare for testing and if we need expanded evaluations done it will have to be on-site. No further information was provided. Initial conclusions show that the event was caused by improper use of the ih6074a/ih61 recliner; operator error. The recliner was quarantined and tested by the facility. Multiple tests demonstrated that the recliner functioned as intended. There was no malfunction or defect associated with the injury allegation. It was reported that the end user's foot was in the chair footrest as the attendant was attempting to raise the recliner. The user manual explicitly warns do not place hands or feet into any openings when adjusting the recliner. Attendant or care provider should always verify placement of user's hands and feet prior to adjusting the recliner. Failure to do so may result in serious bodily injury. A return of the recliner for evaluation is not anticipated at this time, as it was reported that the facility cannot release the recliner to invacare. In conclusion, the underlying cause of the event was that the attendant failed to adhere to the warnings in the user manual. No further investigation will be performed, unless additional information should be provided that indicates an additional underlying cause. 3500a was filed by the facility. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1531186-2016-00021
MDR Report Key6013976
Date Received2016-10-10
Date of Report2016-09-26
Date of Event2016-09-16
Date Facility Aware2016-09-26
Report Date2016-10-06
Date Reported to FDA2016-10-06
Date Reported to Mfgr2016-10-06
Date Added to Maude2016-10-10
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER CAREGIVERS
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name3 POSITION RECLINER-BASIC BLUE RIDGE 9153641336
Generic NameCHAIR AND TABLE, MEDICAL
Product CodeFRJ
Date Received2016-10-10
Model NumberIH6074A/IH61
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age3 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGOODBABY
Manufacturer AddressCH


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-10-10

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