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

Model Number CXX21A4Q2AKBA0

Device Problems Sparking (2595); Electrical Shorting (2926)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow up report once the investigation is completed.

Event Description

Following the information provided by the customer the bed made an electric crackling noise followed by the burning smell.The bed was unplugged immediately and taken out of the room.The staff checked the bed and found that the power cord was cut and burnt.No patient was involved, no injury was sustained.

Manufacturer Narrative

There are visible scorched marks that were a result of short circuit, that occurred when the insulation of wires cracked and the wires made contact.The arjo representative replaced the power cord, which allowed to bring the bed back to working order.The analysis of the available information and photographic evidence was performed in assistance of product engineer.The damage of the power cord is situated in place, in which the cable contacts the side of cable holder.The holder's function is to fix the cord to the frame in a way, that will prevent damages to the power cord socket in the control box, in case the cord was pulled with excessive force during use.If the power cord is pulled when operating the bed, the cable bends in this place over the edge of the holder, stretching out the insulation material and resulting in degradation if such scenario is repeated continuously during use.The ifu for citadel (830.213-en) includes the following information related to handling of the power cord: - "if the power cord or plug is damaged, the complete assembly must be replaced by authorized service personnel.".- "make sure the power cord is not stretched, kinked or crushed.".- "improper handling of power cord can cause damage to the cord, which may produce risk of fire or electric shock.".- "unplug the power cord from the electricity supply, and store it, before moving the bed.".- "visually check power supply cord and mains plug" - it is a preventive maintenance activity to be performed weekly by the caregiver.Arjo device failed to meet its performance specification since the power cord was damaged.The device was not used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of sparks emission and scorched signs on the damaged power cord.

• Brand Name: CITADEL BED FRAME
• 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: 14918093
• MDR Text Key: 296050582
• Report Number: 3007420694-2022-00107
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097370583
• UDI-Public: (01)05056097370583(11)190628
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CXX21A4Q2AKBA0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2019
• 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