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

Device Problem Loss of Power (1475)

Patient Problem Discomfort (2330)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

It was reported to arjohuntleigh that pt has had some problems with the trinova mattress system causing the mattress going flat with the pt laying on metal bars from bed frame for 6 hours.Skin damage was reported as a result of the event.

• Brand Name: TRINOVA
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall; houghton regis, bedfordshire TX L U5 5; UK TX LU5 5X
• 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: 4964121
• MDR Text Key: 6256648
• Report Number: 1419652-2015-00236
• Device Sequence Number: 1
• Product Code: FNM
• 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: 07/29/2015,07/01/2015

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2015
• Distributor Facility Aware Date: 07/01/2015
• Event Location: Other
• Date Report to Manufacturer: 07/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR