MAUDE Adverse Event Report: ALBER GMBH E-FIX E26; MECHANICAL (MANUAL) WHEELCHAIR

Model Number E-FIX E26

Device Problem Detachment Of Device Component (1104)

Patient Problem Bruise/Contusion (1754)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

The incident occurred in (b)(6).The e-fix was returned.The device was manufactured in 2012 and was being used outdoors.No serious injury was reported.An evaluation was completed.The complaint of a broken axle was confirmed but the root cause was unable to be determined with certainty.The malfunction was consistent with findings that would be seen with malfunctions caused by overload.Should additional information become available, a supplemental record will be filed.

Event Description

The device e-fix e26 was used outdoor.The axle was broken after a turn of the wheelchair.

• Brand Name: E-FIX E26
• Type of Device: MECHANICAL (MANUAL) WHEELCHAIR
• Manufacturer (Section D): ALBER GMBH; vor dem weissen; stein 21; albstadt, germany 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen; stein 21; albstadt, germany 72461 ; GM 72461
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6593695
• MDR Text Key: 76244511
• Report Number: 3004730072-2017-00004
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943789
• 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: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: E-FIX E26
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR