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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 UNKNOWN
Device Problems Detachment of Device or Device Component (2907); Unintended Electrical Shock (4018)
Patient Problems Pain (1994); Electric Shock (2554)
Event Date 11/30/2021
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 (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).Process of gathering and 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 the electric shock due to contact with the power cord which was ripped from the nimbus pump.It is unknown if any medical intervention was needed.
 
Manufacturer Narrative
Process of gathering information is still ongoing (we are waiting for additional information from the initial reporter).Additional information will be provided upon conclusion of the investigation.
 
Manufacturer Narrative
It was reported to arjo that a nurse suffered an electric shock after she touched the power cord which had been detached from the nimbus pump.The nurse complained on pain on the left side of her body in the hand, arm and shoulder area.An electrocardiogram (ecg) was carried out and no problems were detected.During an on-site visit, an arjo technician checked the involved device and found that the pump power cord was pulled out of the grommet point exposing the internal copper wires.The customer informed that the cable was pulled out from the pump when the patient's dad stepped on it.The alerted nurse picked up the damaged but still connected to the power socked power cord thinking that the power to the pump was switched off.The investigation conducted by the customer showed three possible causes that may lead to the event.A.The power cord was lying on the floor which means that it was positioned inadequately.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.¿ b.The pump power cord was not suitably internally secured in the clamp.In result, when the cable was under tension, it detached from the grommet point.However even if the power cable was suitably secured, it may have still become disconnected.C.Miscommunication occurred, the nurse picked up the damaged power cord thinking that the power to the pump was switched off.No additional event was reported to us pressing the same issue.Based on the above, it was concluded that the electric shock occurred due to touching of the 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 detached) therefore the device did not meet specification.The pump was in use by a patient when the claimed issue occurred.
 
Event Description
It was reported to arjo that a nurse suffered an electric shock after she touched the power cord which had been detached from the nimbus pump.The nurse complained on pain on the left side of her body in the hand, arm and shoulder area.An electrocardiogram (ecg) was carried out and no problems were detected.
 
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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
katarzyna bobrow
ks. wawrzyniaka 2
komorniki 62-05-2
PL   62-052
668046472
MDR Report Key13058278
MDR Text Key286930889
Report Number3005619970-2021-00024
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeNZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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