MAUDE Adverse Event Report: INVACARE INVACARE MANUAL HOYER LIFT

Model Number 9805P

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

The certified nursing assistant was manually pumping the client up using a hoyer lift, when the handle (pump) separated from the hoyer lift.The client was safely lowered to the chair.The equipment company is delivering a replacement today.The equipment company: (b)(6).

• Brand Name: INVACARE MANUAL HOYER LIFT
• Type of Device: MANUAL HOYER LIFT
• Manufacturer (Section D): INVACARE; * ; *
• MDR Report Key: 4114542
• MDR Text Key: 4837133
• Report Number: MW5038299
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9805P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 59