MAUDE Adverse Event Report: LIKO AB (HILL-ROM INC.) GOLVO; LIFT, PATIENT, AC-POWERED

Model Number 7007ES

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/27/2017

Event Type  malfunction  

Event Description

The golvo lift stopped working while patient was in the sling, being moved to wheelchair after radiation treatment.We were able to use the emergency release to get him safely to his chair.

• Brand Name: GOLVO
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): LIKO AB (HILL-ROM INC.); 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6756381
• MDR Text Key: 81484298
• Report Number: 6756381
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2017

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: 7007ES
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 124