MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PATIENT CARE SYSTEM; BED, FLOTATION THERAPY, POWERED

Model Number CXX22C6M4AMFC0

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

The analysis is ongoing.The conclusions will be provided to the follow-up report.

Event Description

Following information gathered, the arjo technician received an electric shock during repair of citadel bed frame.Ecg did not reveal any injury.

Manufacturer Narrative

The technician was testing the new pump motor to check the pressure output when the bed was connected to the mains power supply.During an attempt to connect the air tube to the pump motor, the metal housing of the motor, held in the technician¿s hand, touched the pcb.As a consequence, the technician received an electric shock.The service manual dedicated to citadel patient therapy system (830.284) warns: ¿disconnect the bed from the mains supply before starting any maintenance activity.¿ ¿do not remove protective covers or open electrical enclosures while the mains power cord is plugged into a wall outlet.¿ ¿electrical equipment can be hazardous if misused.Obey all safety instructions.¿ to sum up, the technician received an electric shock during the repair of the device, no patient was involved, the arjo device failed to meet its specifications at that time.

Event Description

Following information gathered, the arjo technician received an electric shock during the service of the citadel patient therapy system in the service center.An electrocardiogram (ecg) taken after the event, did not reveal any injury.The reason for the device service was a low pressure alarm, triggered by the pump.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 12105834
• MDR Text Key: 264148717
• Report Number: 3007420694-2021-00096
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 05056097313726
• UDI-Public: (01)05056097313726(11)170707
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CXX22C6M4AMFC0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other