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  

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.

• 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: 12419947
• MDR Text Key: 269762015
• Report Number: 1419652-2021-00030
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097370583
• UDI-Public: (01)05056097370583(11)190701
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2021

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2021
• Distributor Facility Aware Date: 08/13/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR