MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 151010

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Electric Shock (2554)

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

It was reported to arjo that a nurse suffered an electric shock after she touched the damaged pump power cord.There was no allegation that any harm occurred.No medical intevention was needed.

Manufacturer Narrative

It was reported to arjo that a nurse suffered an electric shock after she touched the damaged pump power cord.There was no allegation that any harm occurred.No medical intervention was needed.The investigation conducted by the nhs representative showed that the pump power cord had unseen cable damage in the grommet point.The cable had indication of wear and tear in this area, thus causing the cable fail and short circuit.Additionally it was observed that the cable termination block had loose connections.The claimed device was part of arjo rental fleet.It was checked and pat (portable appliance testing) tested on 23 feb 2022 (2 days before it went on rent).Based on the above, it can be assumed the cable damage might have occurred between the delivery to the customer on 25 feb 2022 and 21 mar 2022, when the issue was identified on the ward.The pump was returned to arjo with cut ends of power cord (plug and terminal).The arjo technician stated that the grommet point was damaged either by being trapped, pulled or stretched.The cable converter located inside the pump was in good condition although one pillar holding the cable converter in place was slightly loose.This could occur when 3rd party removed the cable, or loosen up overtime due to constant pulling of the cable.The received cut cable terminal had sliced insulation to show where short circuit occurred.There were seen the charred wires and pinch stretch marks on the wire.This demonstrates that the cable was physically damaged as something pinched this area of the cable.Based on the above, it was concluded that the electric shock occurred due to touching of the mechanically damaged power cord connected to the power.The complaint was assessed as reportable due to allegation about the electric shock (non-serious).The pump was malfunctioned (the cable was damaged) therefore the device did not meet specification.The pump was in use by a patient when the claimed issue occurred.

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14101817
• MDR Text Key: 289685848
• Report Number: 3005619970-2022-00006
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 151010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other