MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB TRINOVA

Model Number 7101

Device Problem Burst Container or Vessel (1074)

Patient Problems Bruise/Contusion (1754); Skin Tears (2516)

Event Date 04/07/2014

Event Type  malfunction  

Event Description

We have been informed that one of mattress cell on trinova system exploded whilst it was under the patient at his home address causing small injury to his arm.Ref# mfr 1000381138-2014-00006.

• Brand Name: TRINOVA
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall; houghton regis, bedfordshire LU5 5XF; UK LU5 5XF
• 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: 3799175
• MDR Text Key: 18934350
• Report Number: 1419652-2014-00118
• Device Sequence Number: 1
• Product Code: FNM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7101
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2014
• Distributor Facility Aware Date: 04/07/2014
• Event Location: Home
• Date Report to Manufacturer: 04/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other