MAUDE Adverse Event Report: HILL-ROM, INC. LIKOGUARD XL; LIFT, PATIENT, NON-AC-POWERED

Catalog Number 3301040

Device Problem Defective Device (2588)

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

Event Date 11/09/2020

Event Type  malfunction  

Event Description

Patient was lifted out of bed using overhead lift with swing.Patient moved over to chair.Lift would not function, and patient lowered using safety cord.After weight of patient was removed from lift, motor resumed working.

• Brand Name: LIKOGUARD XL
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 10867633
• MDR Text Key: 217136214
• Report Number: 10867633
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3301040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 82