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

Model Number CX811A3F3AMAB0

Device Problems No Audible Alarm (1019); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 10/08/2021

Event Type  Injury  

Event Description

Following the information provided the patient fell out of the citadel bed.The customer stated that the bed exit alarm was not activated.The quality checked performed after returning the bed back to service center confirmed that the bed was fully functional, no malfunction was detected.There is no indication of any injury as a result of the event.

Manufacturer Narrative

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

Event Description

Following the information provided the patient fell out of the citadel bed.The customer stated that the bed exit alarm did not sound at the time of the event.The circumstances of the event remain unknown.There is no indication of any injury as a result of the event.The quality check performed after returning the bed back to service center confirmed that the bed was fully functional, no malfunction was detected.The allegation of faulty exit alarm was not confirmed.

Manufacturer Narrative

Based on the collected information the root cause of the investigated event cannot be established.No details regarding circumstances of the fall were possible to be obtained from the customer.Based on the quality check performed after returning the device from the customer no malfunction was detected, the bed was fully functional.The instructions for use for citadel patient care system (b)(6) takes into consideration the risk of patient's fall/inadvertent exit on several occassions: - "specialty surfaces have different shear and support characteristics than conventional surfaces and may increase the risk of patient (.) inadvertent bed exit.Monitor patients frequently to guard against patient entrapment." - "to minimize the risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended." - "whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail/restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family.Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed (.).It is recommended that side rails (if used) be locked in the full upright position when the patient is unattended." arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.The device was performing as intended.No malfunction was found during the device evaluation.This complaint is reportable due to allegation of patient's fall from the bed.

• 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
• 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: 12778033
• MDR Text Key: 282282934
• Report Number: 3007420694-2021-00148
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2015
• 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): Other