MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT MECHANICAL CHAIR/TRANSPORT CHAIR; 890.3100

Model Number ALB19HBFR

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

Dealer alleged that the left side footrest will not stay on the chair.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• Manufacturer (Section G): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4033695
• MDR Text Key: 4800927
• Report Number: 1531186-2014-03456
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• 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
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other