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

Model Number CXX21A6X4AKAB0

Device Problem Sparking (2595)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

Following the information provided there was an allegation of sparks appearing from the citadel bed power cord during plugging in.There was no indication of patient involvement.No injury was sustained.

Manufacturer Narrative

According to the collected information, the hospital staff replaced the power cord plug.The plug was not connected correctly with the wires which resulted in the short circuit.The ifu for citadel bed (830.213-en) includes the following information related to the subject of the investigation: ¿if the power cord or plug is damaged, the complete assembly must be replaced by authorized service personnel.Do not remove the fitted plug, or use a rewireable plug or adapter.¿ ¿visually check power supply cord and mains plug.¿ this procedure has to be done weekly.If the result of this test is unsatisfactory, contact arjo or an arjo-approved service agent.Based on the information provided, it is indicated that the root cause of the investigated scenario was the unauthorized repair of the power cord conducted by the customer staff.Arjo device failed to meet its performance specification since the sparks appeared from the power cord.There was no allegation of any patient involvement.No injury was claimed.The complaint is reportable due to allegation that spark from power cable occurred.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• 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: 16730619
• MDR Text Key: 313194797
• Report Number: 3007420694-2023-00077
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 05056097328492
• UDI-Public: (01)05056097328492(11)22014
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CXX21A6X4AKAB0
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• 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