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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number 151015
Device Problem Unintended Electrical Shock (4018)
Patient Problem Electric Shock (2554)
Event Date 05/16/2022
Event Type  malfunction  
Manufacturer Narrative
Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: 1000381138, 3007420694.Currently, these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration 3005619970.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
 
Event Description
It was reported by a customer representative that one of customer's employees received an electrical shock from a pump power cable.It was also indicated that there was an electrical arc observed by the firefighters.There was no allegation that any patient was involved.It is unknown if any medical intervention was needed.
 
Manufacturer Narrative
It was reported by a customer representative that one of customer's employees received an electrical shock from a nimbus 3 pump power cable.It was also indicated that there was an electrical arc observed by the firefighters.There was no allegation that any patient was involved.It is unknown if any medical intervention was needed.The sale representative contacted with the customer to clarify the circumstances of the event and establish details related to employee outcome.The customer answered only that the cable was damaged in a local emergency situation and no other additional information has been revealed.The involved pump was part of a rental fleet.It was picked up from the customer following the event.Based on photo of the involved device, the power cord was broken in two pieces.It seems the most probable that the sparks were caused by the pump¿s power cord breakage and therefore the customer mentioned that the electrical arc was observed by the firefighters.Electric shock was felt after touching a mechanically damaged power cord, which was connected to the power.The instruction for use (ifu), document 151996en warns ¿make sure that the mains power cable and (¿) are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas.Where cable management flaps are provided along the sides of the mattress, these should be used to cover the mains power cable.¿ the complaint was assessed as reportable due to allegation of an electric shock sustained by the employee.The pump malfunctioned (the cable was mechanically damaged, broken in two pieces) therefore the device did not meet specification.It is unknown if the pump was in use by a patient when the claimed issue occurred.It is unknown how the power cord was damaged and whether the power cord was securely placed in the cable management flaps.
 
Event Description
It was reported by a customer representative that one of customer's employees received an electrical shock from a nimbus 3 pump power cable.It was also indicated that there was an electrical arc observed by the firefighters.There was no allegation that any patient was involved.It is unknown if any medical intervention was needed.
 
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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 Key14641685
MDR Text Key293612744
Report Number3005619970-2022-00011
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
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 06/22/2022
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
Device Model Number151015
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/16/2022
Initial Date FDA Received06/09/2022
Supplement Dates Manufacturer Received05/16/2022
Supplement Dates FDA Received06/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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