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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A & I INDUSTRIES INSIGNIA; WHEELCHAIR, MECHANICAL
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A & I INDUSTRIES INSIGNIA; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number IN88AHANFR
Device Problem Detachment Of Device Component (1104)
Patient Problems Abrasion (1689); Pain (1994); Swelling (2091); Hypoesthesia (2352)
Event Type  Injury  
Manufacturer Narrative
It is unclear if all of the injuries alleged directly resulted from the fall.The hospital intake employee advised that due to hipaa, she was not able to disclose any further details about the patient's injuries, and the patient's wife refused to provide clarification.She advised that she has spoken to a few attorneys, and she will not be answering any further questions.The alleged malfunction cannot be verified, and the underlying cause cannot be determined.The insignia user manual instructs the user to inspect the seat and back for loose or broken hardware on a monthly basis.Additionally, every six months or as necessary, the wheelchair should be taken to a qualified technician for a thorough inspection and servicing.The in88ahanfr wheelchair was manufactured in december 2012; therefore, it has exceeded its expected life of 5 years.A return material authorization was issued, so that the wheelchair could be returned to invacare for an evaluation; however, the patient's wife would not say whether she actually intends to return it.Should the wheelchair be returned or should additional information become available, a supplemental record will be filed.
 
Event Description
A hospital intake employee reported that the patient arrived at the hospital and was admitted due to injuries sustained from falling backwards out of the in88ahanfr wheelchair.The patient's wife alleged that the bar across the back of the chair fell off, causing the patient to fall.She stated that her husband is in a neck brace and that he has extreme swelling in his neck and is in a lot of pain.She alleged that he has developed an allergic reaction to the neck brace and has an open abrasion on the left side of his neck.The patient's wife also reported that her husband has swelling, pain, and redness in his left arm and that he has lost motor and sensory function in his right arm.She indicated that he is regaining motor function, but not sensory function.She advised that her husband is an incomplete paraplegic and that he used to be able to feel his upper thighs, but now the sensory loss starts at his hips.
 
Manufacturer Narrative
Based on information previously provided, it was unclear which part of the chair had allegedly broken.On 06/08/2020, photographs of the chair were received, from which the broken component was able to be identified.The photographs show that the left back cane had fractured through one of the mounting holes.The back canes are responsible for holding the back upholstery in place.Because the left back cane was broken, the left side of the back upholstery was no longer being supported.The underlying cause of this failure remains unknown.No further information was provided.It should be noted that the insignia wheelchair is an obsolete product, which is no longer being sold.
 
Event Description
A hospital intake employee reported that the patient arrived at the hospital and was admitted due to injuries sustained from falling backwards out of the in88ahanfr wheelchair.The patient's wife alleged that the bar across the back of the chair fell off, causing the patient to fall.She stated that her husband is in a neck brace and that he has extreme swelling in his neck and is in a lot of pain.She alleged that he has developed an allergic reaction to the neck brace and has an open abrasion on the left side of his neck.The patient's wife also reported that her husband has swelling, pain, and redness in his left arm and that he has lost motor and sensory function in his right arm.She indicated that he is regaining motor function, but not sensory function.She advised that her husband is an incomplete paraplegic and that he used to be able to feel his upper thighs, but now the sensory loss starts at his hips.
 
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Brand Name
INSIGNIA
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
A & I INDUSTRIES
no. 1 been ting
been tsuoh village
chia-yi shiann, koou shian
MDR Report Key7247686
MDR Text Key99212699
Report Number1531186-2018-00001
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 02/07/2018,01/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIN88AHANFR
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Report Sent to FDA02/07/2018
Distributor Facility Aware Date01/08/2018
Device Age5 YR
Date Report to Manufacturer02/07/2018
Date Manufacturer Received01/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age43 YR
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