MAUDE Adverse Event Report: UNKNOWN MECHANICAL CHAIR/TRANSPORT CHAIR; 890.3100

Model Number ALB19HBFR

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Customer states that armpad plastic hold cracked in half and screws came out.Customer reports not hitting anything and does not fold up for transport.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4120183
• MDR Text Key: 4924883
• Report Number: 1531186-2014-04464
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/25/2014,09/05/2014

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: ALB19HBFR
• 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: 09/25/2014
• Distributor Facility Aware Date: 09/05/2014
• Date Report to Manufacturer: 09/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other