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

Model Number AJL7112-GB

Device Problems Device Tipped Over (2589); Installation-Related Problem (2965); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 05/17/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that during a bathing procedure the bath tipped whilst a resident was situated on the bath seat.The resident was on the chair in the bath and was about to be raised to be removed from the bath.She was raised and as it swung over the edge of the bath the whole bath and resident tilted over and then tilted over onto its side.The resident was then removed from the chair unhurt.No injury occurred to the pt or caregiver as a result of this incident.Ref: # mfr 9611530-2014-00037.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• MDR Report Key: 3952082
• MDR Text Key: 18000330
• Report Number: 1419652-2014-00159
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2014

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: Other
• Device Model Number: AJL7112-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2014
• Distributor Facility Aware Date: 05/21/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/18/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other