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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL BED FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL
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ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL BED FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number CXX21A4Q2AKBA0
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2022
Event Type  malfunction  
Event Description
Following the information provided by the customer representative the sparks were produced by the damaged power cable from the citadel bed frame.The bed was taken out of use.There was no indication of patient involvement.No injury was sustained.
 
Manufacturer Narrative
Following the information provided by the customer representative the sparks were produced by the damaged power cable from the citadel bed frame.The bed was taken out of use.There was no indication of patient involvement.No injury was sustained.The photographic evidence provided revealed that the power cord was damaged.The insulation of the cable was cut and scorched near the edge of the cable holder.The function test was performed and device was not working properly due to no power.No sparks were observed during the device evaluation.The power cord was removed and replaced.The damage of the power cord is situated in a place, in which the cable contacts the bottom side of the cable holder.The holder's function is to fix the cord to the frame in a way, that will prevent detaching the power cord socket from the control box in case the cord is pulled with excessive force during use.If the power cord is excessively pulled or stretched when operating the bed, the cable bends resulting in degradation, if such scenario is repeated continuously during use.The ifu for citadel (830.213-en rev f) includes the following information related to handling of the power cord: "make sure power cord is kept free from all pinch points, moving parts and is not trapped under casters.Improper handling of power cord can cause damage to the cord, which may produce risk of fire or electric shock." "make sure the power cord is not stretched, kinked or crushed." ¿make sure the power cord does not become entangled with moving parts of the bed or trapped between the bed frame and head board.¿ "unplug the power cord from the electricity supply, and store it, before moving the bed." "visually check power supply cord and mains plug" - it is a preventive maintenance activity to be performed weekly by the caregiver.Arjo device failed to meet its performance specification since the power cord was damaged.It is unknown if the device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of sparks produced by the damaged power cord.
 
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Brand Name
CITADEL BED FRAME
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. piotra wawrzyniaka 2
komorniki PL-62 052
PL  PL-62052
Manufacturer (Section G)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. piotra wawrzyniaka 2
komorniki PL-62 052
PL   PL-62052
Manufacturer Contact
justyna kielbowska
ks. wawrzyniaka 2
komorniki 62-05-2
PL   62-052
883337089
MDR Report Key15299724
MDR Text Key305495439
Report Number3007420694-2022-00138
Device Sequence Number1
Product Code FNL
UDI-Device Identifier05056097370583
UDI-Public(01)05056097370583(11)190701
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 Other
Type of Report Initial
Report Date 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCXX21A4Q2AKBA0
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2019
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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