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

Model Number CXX21C4Q1AAAB0

Device Problem Activation Problem (4042)

Patient Problem Bradycardia (1751)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to arjo by the authorized representative in (b)(6) that one of patients (on a ventilator) gone into bradycardia and desaturase and required atropine due to a failure of an arjo bed.At time of the event, a backrest of the citadel bed was locked in a flat position and did not response on any commend given.From the information received, the customer facility used pillows to place the resident in an upright position.

Manufacturer Narrative

We are waiting for additional information to complete the investigation.The cause of the reported issue has not been established yet.

Manufacturer Narrative

The analysis of collected information is ongoing.Conclusions from an investigation will be submitted in the next report.

Manufacturer Narrative

It was reported to arjo by an authorized representative in kuwait that one of their patients (on a ventilator) gone into bradycardia, desaturated and required atropine.At the time of the event the citadel bed was placed in a flat position for patient central venous pressure check.When the customer was trying to raise the backrest section, the bed would not respond.Thus the customer facility used pillows to place the resident in an upright position.On 17 nov 2020 arjo received additional information related to the bed inspection.The visual condition of the bed was very good, the bed functions were not responding due to failure of inside wires located in the side rails.The side rails were replaced and the bed function was restored.According to the available information, the citadel bed was in use for a 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.

• 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: 10641193
• MDR Text Key: 210163620
• Report Number: 3007420694-2020-00159
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CXX21C4Q1AAAB0
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention