MAUDE Adverse Event Report: INVAMEX TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403; WHEELCHAIR, MECHANICAL

Model Number SOLARA3G

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Caller states that the canes are coming loose because the screw is backing out on both back canes.

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Other, hardware loose/stripped/gone.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the right and left recliner assemblies of having loose hardware.It was confirmed that there was missing hardware on both assemblies.Complaint of "canes are coming loose because the screw is backing out on both back canes" was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Other, hardware loose/stripped/gone.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the right and left recliner assemblies of having loose hardware.It was confirmed that there was missing hardware on both assemblies.Caller states that the canes are coming loose because the screw is backing out on both back canes.

• Brand Name: TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
• Type of Device: WHEELCHAIR, 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 Key: 4817503
• MDR Text Key: 5929374
• Report Number: 9616091-2015-01484
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOLARA3G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other