MAUDE Adverse Event Report: UNKNOWN PTD OFFSET TRAPEZE BAR 9153644317; AID, TRANSFER

Model Number 7740P

Device Problems Difficult to Fold, Unfold or Collapse (1254); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by a dealer that upon receiving a 7740p trapeze bar, the chain was welded together incorrectly and will not straighten.

• Brand Name: PTD OFFSET TRAPEZE BAR 9153644317
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4365302
• MDR Text Key: 5258681
• Report Number: 1531186-2014-06811
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/23/2014,11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7740P
• 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: 12/23/2014
• Distributor Facility Aware Date: 11/11/2014
• Date Report to Manufacturer: 12/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other