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

Model Number CXX21A4Q2AKBA0

Device Problem Activation Problem (4042)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477); Syncope/Fainting (4411)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

At this time the cause of the issue in unknown.Collecting of information is ongoing.

Event Description

Based on a copy of the customer report, at the time of toileting when flattening in the bed, a patient had respiratory distress.He was not tolerating lying position.The customer staff tried to raise the backrest section, the error code e410 was displayed.The patient medical condition included bradycardia, desaturation and loss of consciousness.The customer staff kept the patient in a sitting position to perform the maneuvers of ventilatory resuscitation, and niv.The patient regained respiratory stability after 5 minutes and was transferred to other device.

Manufacturer Narrative

On 13 aug 2021 arjo received a copy of the customer¿s report, which stated that, during toileting, when the bed platform was placed in a flat position, a patient, who was not tolerating lying position, developed a respiratory distress.The patient medical condition included bradycardia, desaturation and loss of consciousness.An error code e410 was displayed on the bed¿s control panel, when the customer staff was trying to raise the backrest section.The customer staff manually raised the patient to a sitting position and performed a ventilatory resuscitation, and niv (non-invasive mechanical ventilation).The patient regained respiratory stability after 5 minutes and was transferred to other device.The bed was inspected.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.It is worth mentioning, that in case of this failure occurrence, the bed safety functions are still operational; the citadel plus is equipped with a manual cpr lever which activated in an emergency situation, enables the bed to lower all sections to a flat position, even though the electrical components are inoperative.According to the available information, the citadel bed was used for the patient treatment at the time of the event and therefore it played a role in the reported issue.It failed to meet its performance specification since the backrest section could not be raised.The complaint was decided to be reportable due to patient medical condition.

• Brand Name: CITADEL BED FRAME
• 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
• MDR Report Key: 12419946
• MDR Text Key: 269761364
• Report Number: 3007420694-2021-00117
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097370583
• UDI-Public: (01)05056097370583(11)190701
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CXX21A4Q2AKBA0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR