MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number FXX21C4C3AANBB

Device Problems Positioning Problem (3009); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The bed frame inspection conducted by the arjo technician revealed the backrest actuator malfunction.It will be returned to the manufacturer for evaluation.Additional information will be provided upon conclusion of the investigation.

Event Description

It was claimed that the backrest section of the citadel plus bed frame lowered without any command given.The issue occurred after raising of the backrest.The bed was in use by a patient with breathing difficulties at that time.No injury was claimed.

Manufacturer Narrative

It was claimed that the backrest section of the citadel plus bed frame "gets stuck or slides down".The issue occurred after raising of the backrest.The bed was in use by a patient with breathing difficulties at that time.No injury was claimed.The bed frame inspection conducted by the arjo technician revealed the actuator cpr malfunction.The backrest after pushing button up "it either went up but then started to lower or it just started to jerk".The technician established that the red part on the actuator kept activating the cpr.The actuator was replaced and then tested at the manufacturing site.No fault was found with the component.An allegation of a red part of the actuator activating the mechanical cpr was verified.The red part is a holder that is fixed to the actuator.This red part holds the cables, which, when the cpr release handle is pulled, the cable stretches and the red part activates the backrest actuator, lowering the head section.The operation of the red part was simulated and its position was compared to the photographic evidence provided to the complaint record.It was noticed that the red part on the photograph was slightly moved to the left.When the red part is moved slightly to the left and at the same time the button responsible for raising the backrest is pressed, the backrest can move slightly up but then lowers.Such movement can be described as the backrest getting stuck or sliding down.The red part can be stuck to the left slightly when the cpr cable is stretched.Based on the above, we concluded that the cpr release handle could have been pulled and the head section lowered as expected leaving the bed in a flat position.Then the red part stuck because the cpr cable were stretched.Later, when the user was trying to raise the head section by pushing the button on the side rail control panel, it activated an electronic function causing that the head section slightly raised, but since the red part was stuck to the left, the mechanical cpr activated causing that the head rest could not have been raised to the desired position but it lowered.From the above, the cause of the backrest sliding down/lowering or getting stuck has been defined as red part stuck due to cpr release cable being stretched.This situation has not lead to a serious injury in the past and it is unlikely it will lead to a serious injury or death in the future, therefore such situations will not be considered reportable in the future.In summary, the device failed its specification since the backrest was getting stuck or slinging down, the failure occurred when the device was used for patient treatment.The failure did not influence patient condition, there was no injury.There was also no injury in the past and it is unlikely a serious injury occurs in the future for this situation.

Manufacturer Narrative

The availability of the actuator was confirmed.At this time we are waiting for return of it.The inspection results will be provided in the next report.

Manufacturer Narrative

The allegedly actuator was returned to the manufacturer on 24 jan 2024 and it is waiting for evaluation.Results of the investigation will be provided in the next report.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18363236
• MDR Text Key: 331360498
• Report Number: 3007420694-2023-00304
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05059441335665
• UDI-Public: (01)05059441335665(11)230825
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FXX21C4C3AANBB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2023
• 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
• Patient Sex: Male
• Patient Weight: 130 KG