MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3; FNM

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjohuntleigh, a branch of arjo ltd.Med ab (under registration #(b)(4)).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).Additional information will be provided upon the conclusion of investigation.(b)(4).

Event Description

It was reported by the customer that the main cable which is connected to the pump had become trapped in the metal bed frame and had become frayed.When a customer employee leant across the bed, he received an electric shock.In a result the employee suffered a minor burn to his chest and numbness to his arm.The injured attended accident and emergency but was discharged.

Manufacturer Narrative

An investigation was carried out into this complaint.The customer reported that their employee received an electric shock when leant across the bed to help the patient up.The device was inspected by the customer who found that the main cable which is connected to the pump had become damaged and frayed, probably, by being caught in bed frame mechanism (wheel).A review of photographic evidence provided by the customer confirms customer's evaluation.The main cable, which is connected to the pump, had outer covering damaged in several places, one of them had internal insulation integrity broken.When reviewing reportable events, we have found other cases presenting scenarios of hazardous situations related to mains cable insulation integrity breakage.As the mains cable is a critical component of pump assembly, it is very important to consider and follow all the safety warnings and general maintenance rules provided in instruction for use.Product instruction for use (151996en_04 dated october 2009) warns: "warning.Make sure the mains power cord and tubeset are positioned to avoid causing a hazard"."caution.Make sure the mains power cord and tubeset are clear of moving bed mechanism or other possible entrapment areas." "check all electrical connections and the mains power cord for signs of excessive wear".The customer stated that "the mains lead to the mattress control unit had been damaged in several places presumably by being caught up in the bed wheels when being moved, and that one of the damaged areas also had an exposed conductor ".This would indicate that two points from the above ifu warnings have not been followed.In summary, the nimbus 3 pump was being used for patient therapy at the time of the event and in that way played role in the incident, the product failed to meet the manufacturer's specification (power cord failure) as a result of misuse.

• Brand Name: NIMBUS 3
• Type of Device: FNM
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• MDR Report Key: 7380953
• MDR Text Key: 104155715
• Report Number: 3007420694-2018-00075
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2018
• Distributor Facility Aware Date: 11/30/2017
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR