MAUDE Adverse Event Report: UNKNOWN TRANSFER BENCH 9153631800; ADAPTOR, HYGIENE

Model Number 9670

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

The legs are bowing.Per the technician's evaluation, it is confirmed that the unit is uneven and wobbly due to the legs bowing.

• Brand Name: TRANSFER BENCH 9153631800
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5750839
• MDR Text Key: 48866205
• Report Number: 1525712-2016-02248
• Device Sequence Number: 1
• Product Code: ILS
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/10/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2012
• 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