MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVERIGN (INCL. DIGNITY)

Model Number AZL23110-GB

Device Problems Use of Device Problem (1670); Device Operational Issue (2914); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/08/2014

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh representative that caregiver was operating the chair lift of the malibu bath to take the patient out of the bath.While raising the patient the operation faltered a few times but continued with the transfer after jiggling the cable.The lift stopped operating when it was at full height and had rotated 90 degrees to the left.The patient was too frail to support herself in the chair without assistance and caregiver called for the help of a trainee carer.Together they lifted the patient down from the malibu chair to a wheelchair.During the lifting the caregiver took most of the weight straining her back.Strained back was a result of lifting the patient out of the bath a the chair lift didn't work.Ref mfr report 9611530-2014-00034.

• Brand Name: MALIBU/SOVERIGN (INCL. DIGNITY)
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• MDR Report Key: 3908515
• MDR Text Key: 4668587
• Report Number: 1419652-2014-00147
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AZL23110-GB
• 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: 06/03/2014
• Distributor Facility Aware Date: 05/08/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 103 YR
• Patient Weight: 40