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

Model Number CX811A3F3AMAB0

Device Problems Fire (1245); Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

Following the information provided, the patient had stored some items under the bed, or top of the flat area and it caught fire.There is no indication of patient involvement at the time of event.No injury was sustained.The photographic evidence provided shows that the patient's items were stored on the cover of (b)(6) box, which is mounted to the base frame.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within follow-up report once available.

Manufacturer Narrative

The evaluation of the bed that was performed by the arjo representative revealed that the grounded threaded pin, on which the transformer is mounted, was too long.As a result of pressure imposed on the cover by personal items stored on the ebay box and the bed¿s frame lowering onto the items the pin made contact with the cover, scratched the paint layer from it and touched raw metal plate, creating an additional electrical circuit through the threaded pin and the cover.As a result of a current flow through this circuit, the ebay cover overheated in the spot where the pin made contact with it, resulting in smoldering of the personal belongings that were placed on top of the box.Arjo performed simulations at the manufacturing site, attempting to recreate the fault condition.The simulation confirmed the reported issue.The tested fault condition (constant current flow causing overheating) lasted 12 hours.No damages of components placed inside the ebay box (pcb, battery, wires and transformer) were noticed.The only outcome was visible heat damage on paint layer on both sides of the ebay box cover.The instructions for use for citadel bed frame system (830-213-en rev.J) includes the following information related to the subject of the investigation: "when the bed is operated, make sure that obstacles such as feet, oxygen bottles, bedisde furniture or any other objects do not restrict its movement"."to avoid potential damage or injury, do not leave oxygen bottle or any other obstacles under the bed frame while operated'." keep all equipment away from moving parts and pinch points.Do not leave oxygen bottle or any other obstacles under the bed frame while operated".Based on the collected information it is concluded that the complained scenario is a result of double fault condition - insufficient design of the bed combined with use error.Arjo device failed to meet its performance specification since the insufficient design of the threaded pin was identified.There is no indication that device was used for a patient treatment when the failure occurred.This complaint is deemed reportable due to allegation of smoldering of patient's belongings as a result of device overheating.

Event Description

Following the information provided, the patient had stored some items under the bed, on top of the flat area and the belongings started to smolder.There is no indication of patient involvement at the time of event.No injury was sustained.The photographic evidence provided shows that the patient's items were stored on the cover of (b)(4) box, which is mounted to the base frame.The (b)(4) box contains pcb, transformers, batteries and wiring connecting those components.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within follow-up report once available.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within follow-up report once available.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13341789
• MDR Text Key: 284351934
• Report Number: 3007420694-2022-00008
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)201119
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• 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