MAUDE Adverse Event Report: ANI [ A&I ] GROUP TAIWAN INSIGNIA/WD88/ADULT/HGTADJARM/ANGLE/ANTITIP/FTRST 9153650894; WHEELCHAIR, MECHANICAL

Model Number IN88AHANFR

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer is stating the end user is alleging that the wheel is loose and brake is not locking in place.Dealer is stating that they replaced chair in (b)(6) 2014, but did not have serial number at the time of call.

• Brand Name: INSIGNIA/WD88/ADULT/HGTADJARM/ANGLE/ANTITIP/FTRST 9153650894
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): ANI [ A&I ] GROUP TAIWAN; no. 1 been ting; been tsuoh village; chia-yi shiann ; TW
• MDR Report Key: 4431461
• MDR Text Key: 20124521
• Report Number: 1531186-2015-00382
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/17/2015,01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IN88AHANFR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2015
• Distributor Facility Aware Date: 01/07/2015
• Date Report to Manufacturer: 01/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other