MAUDE Adverse Event Report: INVACARE CORP. HOYER LIT MEDACURE FREE SPIRIT PATIENT LIFT; LIFT, PATIENT, AC-POWERED

Model Number FS660-T

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  Injury  

Event Description

An invcare hoyer lift washer that held the main lift bar to the pivot bar bent and caused the welded joint to fail causing a fall.

• Brand Name: HOYER LIT MEDACURE FREE SPIRIT PATIENT LIFT
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 18809756
• MDR Text Key: 336695156
• Report Number: MW5152168
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS660-T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White