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

Device Problem Activation Problem (4042)

Patient Problem Head Injury (1879)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Following information gathered, the electric cardiopulmonary resuscitation (cpr) did not work while a patient medical intervention was required.The e410 error was displayed on the control panel.The patient was intubate the in a sitting position.As a consequence of the event the patent sustained a cervical trauma.The arjo representative visited the hospital to evaluate the bed.The bed functional inspection showed that the bed¿s functions were not responding due to electrical failure of wires located in the side rails and therefore an error code e410 was displaying on the control panel.Also the bed visual inspection showed scratches on 4 safety sides and head panel and protection of the cpr buton was broken on both safety sides.Left foot safety side was bent.The emergency cpr did not work immediately when the medical intervention was required.However, the failure of the electrical cpr error does not prevent conducting cpr.The manual cpr lever is operational and can be activated in an emergency if necessary.The manual cpr lever allows to lower the backrest section of the bed's platform to the horizontal, flat position, even if the electrical components are inoperative.The instructions for use dedicated to citadel bed frame system (830.213-en) states: "in a fault or power loss condition where the cpr button is not responding, use the cpr backrest release to position the patient for cpr." arjo device failed to meet its performance specification since the electrical cpr failure was observed when medical intervention was required.The complaint decided to be reportable due to electrical cpr malfunction in the emergency situation.No injury was claimed.

Event Description

Following information gathered, the electric cardiopulmonary resuscitation (cpr) did not work while a patient medical intervention was required.The e410 error was displayed on the control panel.The patient was intubate the in a sitting position.As a consequence of the event the patent sustained a cervical trauma.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• 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: 16722346
• MDR Text Key: 313126808
• Report Number: 3007420694-2023-00076
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097358031
• UDI-Public: (01)05056097358031(11)181211
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 85 KG