MAUDE Adverse Event Report: ARJOHUNTLEIGH MEDICAL BEDS DIVISION ACCESSORIES - MEDICAL BEDS; NONE

Model Number MB-ACC34

Device Problems Break (1069); Detachment Of Device Component (1104); Device Maintenance Issue (1379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

It has been indicated by the customer that "the handle of the lifting pole is broken off".The device was inspected at the user's facility by an arjohuntleigh representative, who confirmed that during attending to hygiene cares, the pt wanted to reposition herself with use of the lifting handle in order to sit more straight up.Making this movement the handle broke away from belt retractor housing.The handle broke and the pt fell on the bed.There was no injury, pt was not hospitalized because of the event and was not taken to the emergency room.

• Brand Name: ACCESSORIES - MEDICAL BEDS
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH MEDICAL BEDS DIVISION; trident dr, unit 3 britannia park; wednesbury WS10 7XB; UK WS10 7XB
• 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: 3723697
• MDR Text Key: 4276426
• Report Number: 1419652-2014-00017
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MB-ACC34
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2014
• Distributor Facility Aware Date: 12/16/2013
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 105