MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB CAIRWAVE/RENAISSANCE

Model Number SA802

Device Problem Electrical Shorting (2926)

Patient Problem Electric Shock (2554)

Event Date 10/30/2013

Event Type  Injury  

Event Description

It has been reported that a student nurse received an electrical shock from the mattress's electrical lead which was caught in the bed rails.The bed rails were placed exposing electrical wires of lead and causing electrical sparks.As an immediate action the pump was turned off suing main switch.Mattress and pump were removed and checked.Arjohuntleight has been informed in (b)(4) 2014 about the event occurred in (b)(6) 2013.Ref mfr #1000381138-2014-00004.

• Brand Name: CAIRWAVE/RENAISSANCE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall; houghton regis, bedfordshire LU5 5XF; UK LU5 5XF
• MDR Report Key: 3897337
• MDR Text Key: 4427506
• Report Number: 1419652-2014-00033
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2014
• Distributor Facility Aware Date: 01/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other