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

Model Number AJR7112-GB

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Laceration(s) (1946)

Event Date 02/18/2014

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh rep that the shower handset dropped from holder striking resident on left shin causing laceration.Quick release part of handset was still screwed into hose.Ref # mfr 9611530-2014-00021.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• MDR Report Key: 3737990
• MDR Text Key: 15937437
• Report Number: 1419652-2014-00080
• 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: 03/26/2014,02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AJR7112-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: 03/26/2014
• Distributor Facility Aware Date: 02/25/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 62