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

Model Number FX711B3B4AMABB

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

It was claimed by the nurse that the citadel plus bed frame was damaged and new bed is needed for the patient weighting about 500 lbs.The arjo representative arrived to the customer facility and established that one of the side rail panels was detached.The bed was in use.No injury was claimed.The technician observed that the width extension sections which allow to extended the width of the bed were not used (the bed overall width is 40,6 in / 103 cm) although the mattress placed on the bed (arjo maxxair ets serial number: (b)(4) was set on width 48 in / 121,9 cm).When extension frames were not used, the mattress could push on the side rail, resulting in their damage and subsequent detachment.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 all eight width extension sections are extended.Using the bed without all extensions in the same position may cause damage to the bed as well as create an unsafe condition.¿ 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.Based on the above, it has been determined that the side rail was damaged by the pressure forces caused by too wide mattress inserted in the bed frame (whose width has not been extended to fit the width of the mattress).Arjo device failed to meet its performance specification since the side rail panel was detached from the side rail mechanism.The bed frame was in use.This complaint is deemed reportable due to an allegation of safety side detachment.

Event Description

It was claimed by the nurse that the citadel plus bed frame was damaged and new bed is needed for the patient weighting about 500 lbs.The arjo representative arrived to the customer facility and established that one of the side rail panels was detached.The bed was in use.No injury was claimed.

• 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 Key: 16020659
• MDR Text Key: 308372588
• Report Number: 3007420694-2022-00209
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FX711B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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: 227 KG