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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL
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ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number FX811B3B4AMABB
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2024
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.The results will be provided in final report.
 
Event Description
The customer reported that the citadel plus bed side rail panel won¿t go up and stay up.The device inspection revealed that the lower arm that is part of the side rail assembly was broken in two pieces.It was confirmed by the photographic evidence provided no patient was involved when the issue occurred.No injury was claimed.The bed was swapped out and repaired.
 
Event Description
The customer reported that the citadel plus bed side rail panel won¿t go up and stay up.The device inspection revealed that the lower arm that is a part of the side rail assembly was broken in two pieces causing partial side rail detachment.It was confirmed by the photographic evidence provided.Arjo was informed that the bed was damaged when the customer staff was entering the room.The bed was not in use by the patient at that time.No injury was claimed.The bed was swapped out and repaired.
 
Manufacturer Narrative
The customer reported that the citadel plus bed side rail panel won¿t go up and stay up.The device inspection revealed that the lower arm that is a part of the side rail assembly was broken in two pieces causing partial side rail detachment.It was confirmed by the photographic evidence provided.The bed was not in use by the patient at that time.No injury was claimed.The bed was swapped out and repaired.Based on the collected information, the side rail was damaged when the customer staff was transferring the bed, the collision with the door frame occurred at that time.According to citadel plus instructions for use (ifu, 831.374 rev.11, extract attached) there is needed to ¿ensure pathway is clear of cords, hoses and obstacles before driving bed forward or backwards¿ additionally, the safety sides shall be checked every day by caregiver.If the malfunction is identified, arjo or approved service agent should be contacted.Moreover, when the bed was inspected, it was found that the tilt switch cable ft was damaged.However it is not related to the side rail partial detachment and did not affect the investigation results.To sum up, based on the analysis of the complaints concerning side rail detachment, the external excessive force must first compromise the integrity of the safety side prior to breaking it.In the analysed case, the side rail was damaged due to collision with the door frame.The bed frame was damaged, therefore the arjo device did not meet specification.The bed was not in use by the patient at that time.No injury was claimed.The complaint was assessed as reportable due to the detachment of the side rail.
 
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Brand Name
CITADEL PLUS
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 Key19171255
MDR Text Key340905290
Report Number3007420694-2024-00111
Device Sequence Number1
Product Code FNL
UDI-Device Identifier05055982756532
UDI-Public(01)05055982756532(11)201023
Combination Product (y/n)N
Reporter Country CodeUS
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 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberFX811B3B4AMABB
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2020
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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