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

Device Problem Electrical Shorting (2926)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Event Description

Ref imp #(b)(4).

Manufacturer Narrative

(b)(4).Review of post market surveillance data mdr/adverse events from 2008 to date, revealed that there were 7 similar events associated with the arjohuntleigh pressure air care products with no serious consequences to the user.It is also worth to noting that ther were no reported adverse events to the relevant competent authority relating to the renaissance therapy system since 2008; based on info provided by customer we can confirm that the mains cable insulation integrity broke (causing exposed live wires) and thereby caused a risk of electrical shock.All info indicates that the root cause of this event was inadequate controls by the user for safeguarding the mains cable during use and entrapment by moving bed mechanisms when the side rail were repositioned.We (arjohuntleigh) have been informed that the student nurse suffered an electric shock, after which she was assessed by a doctor on ward, and taken by ambulance to the hospital, where she was accessed and discharged the same day.The mains cable is a fundamental part of the system and as such should be regarded as a critical component which should be regularly inspected for any signs of excessive wear or damage.Furthermore the general safety warning included in the product instruction for use (#i(b)(4)) is following: "ensure the mains (power supply) cable is not trapped or twisted and is routed suitably to avoid crushing or entrapment when connected to the product." it is unk if the device was being used for either treatment or diagnosis when the event occurred.It did contribute to the outcome of the event as it was not to specification and as a result gave a caregiver an electrical shock.We take all issues of this nature seriously and will continue to monitor any future trends that may arise from the use of our products, however based on the info provided, we believe the contributing factor in the power cable damage was the failure to adequately management of the power cable.

• Brand Name: CAIRWAVE/RENAISSANCE
• Manufacturer (Section D): ARJOHUNTLEIGHT, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall; houghton regis, bedfordshire LU5 5XF; UK LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5XF; UK LU5 5XF
• Manufacturer Contact: pamela wright ; 12625 wetmore; suite 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3897313
• MDR Text Key: 4674577
• Report Number: 1000381138-2014-00004
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Remedial Action: Repair
• Type of Report: Initial

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?: No
• Device Operator: Other
• Distributor Facility Aware Date: 01/08/2014
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1