MAUDE Adverse Event Report: MASS CORPORATION/MAXHEALTH CAREX TRANSPORT CHAIR

Model Number FGA22600 0000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 09/27/2015

Event Type  Injury  

Event Description

Called in requesting a left back handle for the a226.Care giver put wife in the car in the transport chair and took a corner and wife fell over backwards in the chair and ended up in the emergency room.Caller said it was no fault of the chair was the negligence of care giver not to strap her in.Chair is only 1 mos old.

• Brand Name: CAREX TRANSPORT CHAIR
• Type of Device: TRANSPORT CHAIR
• Manufacturer (Section D): MASS CORPORATION/MAXHEALTH; 15f-6, no.81, sec. 1, hsin tai; taiwan, hsi chih, taipei hsien ; TW
• MDR Report Key: 5192017
• MDR Text Key: 29973246
• Report Number: 2182780-2015-00018
• 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: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FGA22600 0000
• Device Catalogue Number: FGA22600 0000
• 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: 10/30/2015
• Distributor Facility Aware Date: 09/30/2015
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 10/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other