MAUDE Adverse Event Report: HENYI ENTERPRISE PTD TRAPEZE FLOOR STAND 9153644318; AID, TRANSFER

Model Number 7714P

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The dealer reported that the base of the 7714p trapeze would not lay flat on the ground.

• Brand Name: PTD TRAPEZE FLOOR STAND 9153644318
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): HENYI ENTERPRISE; no. 386-3 qingnian street; heping district; shenyang 1100 04; CH 110004
• MDR Report Key: 4400918
• MDR Text Key: 5124635
• Report Number: 1531186-2015-00157
• 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: 01/08/2015,12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7714P
• 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: 01/08/2015
• Distributor Facility Aware Date: 12/22/2014
• Device Age: 1 YR
• Date Report to Manufacturer: 01/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other