MAUDE Adverse Event Report: PINGHU WEIFENG MATERIAL TECHNOLOGY CAREGUARD TOOL-LESS TRANSFER BENCH 2/CARTON 9153645723; ADAPTOR, HYGIENE

Model Number 98071

Device Problem Bolus mechanism failure (1067)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The dealer reported that one suction cup leg broke where the screw attaches the suction cup to the leg of the 98071 transfer bench in question.

• Brand Name: CAREGUARD TOOL-LESS TRANSFER BENCH 2/CARTON 9153645723
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): PINGHU WEIFENG MATERIAL TECHNOLOGY; pinghu ; CH
• MDR Report Key: 4435183
• MDR Text Key: 5378144
• Report Number: 1531186-2015-00452
• Device Sequence Number: 1
• Product Code: ILS
• 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: 01/20/2015,01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 98071
• 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: 01/20/2015
• Distributor Facility Aware Date: 01/12/2015
• Device Age: 7 MO
• Date Report to Manufacturer: 01/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other