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

Model Number FX811B3B4AMABB

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Decreased Respiratory Rate (2485)

Event Date 09/04/2021

Event Type  Injury  

Event Description

Arjo was received a copy of medwatch report ((b)(4)) in which was indicated that a patient fell from an citadel plus bed and was found on the floor with detached endotracheal tube.After the fall, the patient was connected to a bag valve mask and manually administered breaths.The patient was lifted to a gurney and transported for stats computed tomography.No fractures were noted.It was noted by the customer that the patient was deeply sedated and paralyzed so it is unknown why the patient fell from the bed.

Manufacturer Narrative

Additional information will be provided upon completion of the investigation which is currently ongoing.

Manufacturer Narrative

We are still waiting for access to the involved device to perform its evaluation.Additional information will be provided upon completion of the investigation which is ongoing.

Manufacturer Narrative

No arjo inspection of the involved device has been performed yet due to lack of access to the bed frame.Additional information will be provided upon completion of the investigation which is currently ongoing.

Manufacturer Narrative

Arjo received a copy of medwatch report (uf report # (b)(4)) in which was indicated that a patient fell from a citadel plus bed and was found on the floor by the nurse with detached endotracheal tube.After the fall, the patient was connected to a bag valve mask and breaths were manually administered.The patient was lifted to a gurney and transported for stats computed tomography.No fractures were noted.The customer¿s representative noted in the report that it is unknown how the patient fell from the bed.The patient was deeply sedated and paralyzed.The radiologist who was in the room 15 minutes before the event stated that they put the side rail up before leaving the room.The side rails were found to be in down position when the patient laid on the floor.Side rail functionality could not be verified due to lack of access to the involved device.It was quarantined by the customer for their internal investigation and is not available for further arjo evaluation.The patient fell from the arjo device therefore the device played a role in the event.It is unknown if the bed met its specification because it was not available for arjo inspection.The complaint was assessed as reportable due to indication about the patient¿s fall resulted in the serious injury.H3 other text: lack of client consent.

Manufacturer Narrative

The involved bed frame was picked-up from the customer on 17 mar 2022 and inspected.I was found that the side rail panel was bent and separated from the side rail mechanism.It is unknown if this damaged occurred before or at time of the patient¿s fall from the bed frame therefore the root cause is still unknown.Sum up, the patient fell from the arjo device therefore the device played a role in the event.The device side rail was damaged so the bed did not meet its specification.The complaint was assessed as reportable due to indication about the patient¿s fall resulted in the serious injury.

• Brand Name: CITADEL PLUS
• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 12670910
• MDR Text Key: 284196850
• Report Number: 3007420694-2021-00139
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)200527
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2020
• 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): Hospitalization; Required Intervention
• Patient Weight: 120 KG