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

Model Number CX811A3F3AMAB0

Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoxia (1918)

Event Type  Death  

Manufacturer Narrative

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

Event Description

The complaint concerns citadel bed.The customer alleged that during a patient¿s code blue (secondary to hypoxia as per the customer) the bed could not be raised very high and therefore the staff had difficulties with securing an airway for approximately 10 minutes.The physician requested the bed to be raised, however it was not possible to do so.The physician was squatting trying to obtain an airway.The customer complained that it should be easy to raise the bed for procedures.The staff pointed out that due to this issue the code time was longer, there was a high risk for anoxic brain injury and the patient was longer without oxygen.On 18-oct-2022 arjo received a follow-up information stating that the patient ultimately passed away from anoxic brain injury.The contribution of the device malfunction to the outcome cannot be excluded.The evaluation of the bed performer after the event revealed that the bed was working according to the specification, no malfunction was identified.

Event Description

Following the information provided by the customer, during a patient¿s code blue (secondary to hypoxia as per the customer) the bed could not be raised and therefore the staff had difficulties with securing an airway for approximately 10 minutes.The physician requested the bed to be raised by assisting staff, however it was not possible to do so.The physician was squatting trying to obtain an airway.The customer complained that it should be easy to raise the bed for procedures.The staff pointed out that due to this issue the patient's code time was longer, there was a high risk for anoxic brain injury, and therefore the patient¿s time without oxygen was increased.On 18-oct-2022 we received a follow-up information stating that the patient ultimately passed away from anoxic brain injury.The contribution of the device impact to the outcome could not be excluded according to the customer.

Manufacturer Narrative

The device was taken out of use after the event.A thorough inspection performed by arjo service repair technician on 03-nov-2022 did not reveal any malfunctions of the device.The arjo technician checked all functions, including the cpr functions with the simulated patient's load on the bed and was able to successfully restore the bed positioning functions after cpr.The bed performed as intended.Since no malfunction was identified and the issue was not possible to be duplicated, the root cause of the complained inability to raise the bed in emergency situation cannot be determined.Arjo device failed to meet its performance specification since the bed platform position could not be changed in an emergency situation.The device was used for a patient treatment when the alleged problem occurred.The patient eventually passed away as a result of an anoxic brain injury.This complaint is deemed reportable due difficulties to operate the bed in an emergency situation, which contribution to the patient's outcome cannot be excluded.

• 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: 15787821
• MDR Text Key: 303555749
• Report Number: 3007420694-2022-00185
• 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: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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): Death
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 58 KG