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

Model Number CRF

Device Problem Device Tipped Over (2589)

Patient Problem Fall (1848)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Crossfire wheelchair tipped forward at the delivery of product and end-user fell down.A callback from the dealer stated that the chair tipped over the first time the end user was placed in it.

Manufacturer Narrative

Top end has received this crossfire and has reviewed and examined the product.It is manufactured to specification, but appears to have been adjusted to an aggressive center-of-gravity by the provider.Users may desire such an aggressive cg setting - removing weight from the front of the chair so that they can easily raise the front of the chair to clear obstacles during travel.This is a skill that requires development.Top end was unable to duplicate the malfunction listed in the issue description.There is no malfunction or serious injury alleged; therefore, this is not an fda reportable event.

Event Description

Crossfire wheelchair tipped forward at the delivery of product and end-user fell down.A callback from the dealer stated that the chair tipped over the first time the end user was placed in it.

• Brand Name: TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE TOP END; pinellas park FL
• Manufacturer (Section G): INVACARE TOP END; pinellas park FL
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5390451
• MDR Text Key: 37039941
• Report Number: 1056571-2016-00010
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

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: CRF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2015
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• 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
• Patient Sequence Number: 1