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

Model Number FX811B3B4AMABB

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2024

Event Type  malfunction  

Event Description

The customer staff contacted arjo and informed that the side rail broke and the patient fell from the bed.No injury occurred.The photographic evidence provided revealed that the left foot side rail was partially detached form the bed, the screws holding the panel to the bed frame were ripped off.

Manufacturer Narrative

During the interview, the customer stated that the side rail was not in the up position at the time when the event occurred.The caregivers used only the patient's right and left head end side rails.The caregivers noticed the patient was sliding off the bed in place where the foot end side rail was not raised and assisted the patient to the fall pads.The patient involved in the event was at "fall" risk.The review of post-market surveillance data and the investigation carried out at the manufacturer site revealed that the main factor that could lead to the side rail damage might be related to an excessive force applied to the side rail.This is in line with the side rail condition and the information concerning the circumstances of the event.The side rail was mechanically damaged by the patient slipping out of the bed who allegedly pulling and kicking the side rail before the event.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.The side rail was damaged and from that perspective, the citadel plus bed did not meet the performance specification.The device was in use when the event occurred.Although no injury occurred, we report this incident due to the patient¿s fall from the arjo bed frame.

• 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: 18948487
• MDR Text Key: 338312190
• Report Number: 3007420694-2024-00084
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)220311
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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