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

Model Number AJR1334-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 04/30/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that after bathing the resident, the chair was used to remove the client out of the bath.At the same time the bath water was being drained, the chair swung out from the tub and the bath toppled over with the client still in the chair.The client was transferred for xrays but not detained, was shaken up as a result of this.No other injuries occurred as a result of this incident.Ref mfr# 9611530-2014-00033.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3888134
• MDR Text Key: 18367238
• Report Number: 1419652-2014-00144
• Device Sequence Number: 1
• Product Code: ILM
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2014

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: AJR1334-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: 05/29/2014
• Distributor Facility Aware Date: 05/01/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 55