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

Model Number FXX21A4A4AKFBB

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Pain (1994); Subluxation (4525)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

It was claimed that when the staff member was rolling a patient on a bed, a side rail collapsed.As a result, the patient fell from the citadel plus bed frame.It caused the injury to the patient and the nurse.The staff arm was caught under the patient causing soft tissue injury of the nurse¿s shoulder.The patient fell on the knees which resulted in kip, knee and ankle pain, and the dislocation of the patient¿s knee.The bed¿s inspection conducted following the event by the arjo technician revealed that the incorrect air mattress (non-arjo) was being used on the bed.It was too wide causing difficulties in the side rail locking.

Manufacturer Narrative

Based on the collected information, the side rails locked correctly but a lot of pressure had to be applied to lock them.It was caused by too wide mattress (3rd party product) inserted in the bed frame (which width has not fit the width of the bed frame).In the claimed case, it seems most probable that the side rail was not locked correctly therefore it was released when was loaded by the patient.The opening of the side rail resulted in the patient¿s fall from the bed.The instruction for use for citadel plus bed frame (831.374-en) instructs user to: ¿always use a mattress of the correct size and type.Incompatible mattresses can create hazards.¿ ¿make sure the locking mechanism is securely engaged when the side rails are raised.¿ additionally, the operation of the side rails should be checked daily by the device owner.If the malfunction is identified, arjo or approved service agent should be contacted.Sum up, it has been determined that too wide mattress was inserted in the bed frame.The side rail disengaged during use and from that perspective the citadel plus bed did not meet the performance specification.The device was in use by the patient and therefore it played a role in the event.The complaint was assessed as reportable due to the side rail disengagement during the use that resulted in the patient's fall.The event resulted in the serious injury.

• 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: 18433942
• MDR Text Key: 331865044
• Report Number: 3007420694-2024-00001
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756679
• UDI-Public: (01)05055982756679(11)171005
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FXX21A4A4AKFBB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 255 KG