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

Model Number HTR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Type  No Answer Provided  

Event Description

Facility advised, they have a lot of these chairs, and eight residents have fallen, or been injured because they are standing on the foot section, and causing the whole chair to flip over; or leaning forward and causing whole chair to flip over.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4086081
• MDR Text Key: 4853024
• Report Number: 1525712-2014-05782
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HTR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2014
• 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