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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX 9RC 9000 XT RECLINER 9153638254 WHEELCHAIR, MECHANICAL

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INVAMEX 9RC 9000 XT RECLINER 9153638254 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number 9TPZ
Device Problems Bent (1059); Break (1069); Out-Of-Box Failure (2311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

The product was returned for evaluation, and subsequent testing verified the complaint of a bent wheel; however, it was identified that it was the left wheel (and hand rim), not the right. The underlying cause was identified as freight damage. Should additional information become available, a supplemental record will be filed.

 
Event Description

The customer said this chair arrived with some damage. The right rear wheel is bent, the hand rim too. She is thinking they probably just need a whole new chair because they think that the integrity of the chair has been compromised. The product was returned for evaluation, and subsequent testing verified the complaint of a bent wheel; however, it was identified that it was the left wheel (and hand rim), not the right.

 
Manufacturer Narrative

Additional/updated information was added to reflect the device receiving an expanded evaluation, which further identified that four of the six pins connecting the left hand rim to the wheel were bent.

 
Event Description

The customer said this chair arrived with some damage. The right rear wheel is bent, the hand rim too. She is thinking they probably just need a whole new chair because they think that the integrity of the chair has been compromised. The product was returned for evaluation, and subsequent testing verified the complaint of a bent wheel; however, it was identified that it was the left wheel (and hand rim), not the right. An expanded evaluation was performed and further identified that four of the six pins connecting the left hand rim to the wheel were bent.

 
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Brand Name9RC 9000 XT RECLINER 9153638254
Type of DeviceWHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer (Section G)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5331523
MDR Text Key34978741
Report Number9616091-2015-02973
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 01/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number9TPZ
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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