MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT 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 Date 10/21/2014

Event Type  No Answer Provided  

Event Description

The dealer states that the screw insert on the arm pad fell out.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 4240710
• MDR Text Key: 5061276
• Report Number: 1531186-2014-05492
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/10/2014,10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2014
• Distributor Facility Aware Date: 10/22/2014
• Device Age: 4 MO
• Date Report to Manufacturer: 11/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other