MAUDE Adverse Event Report: ARJOHUNTLEIGH AB CITADEL PLUS; BARIATRIC BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number FX811B8B4AMABB

Device Problems Device Displays Incorrect Message (2591); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Pain (1994)

Event Date 02/26/2019

Event Type  malfunction  

Event Description

Patient transferred from icu to medsurg room on a bariatric bed during the night.At 01:20 rn heard bed alarm going off in one of the rooms.Rn ran into the room and found the patient on his side facing the window with the lower left side rail completely separated from the bed.No visible injury noted but patient complained of side pain until he was placed in bed.Rn deployed a patient lift to place patient back in same bed and rn provided sitter until replacement bed arrived.Patient transferred to replacement bed and failed bed was sequestered for follow up and reporting to risk mgt and biomedical engineering.Inspection of bed by biomedical noted complete separation of side rail panel from mounting and locking frame.The mounting assembly still had 4 each mounting screws which were still attached to the side rail attachment rivets.Biomedical's maude database search noted recent events involving loose and detached side rails with this model bed.Biomedical suspected that patient may have tried to kick side rail free in effort to exit bed, but determined cause may be different based on recent reported failures reviewed in the maude database.Bed transferred to the manufacturer for return and analysis.Biomedical to monitor and report any additional side rail failures and inform the rental agency not to move or position bed by the use of raised side rails.Manufacturer response for hospital bed, bariatric, citadel plus (per site reporter).Rental fleet account manager informed of incident and discussed with biomedical and clinical staff.Acct manager informed that they will investigate and report back their findings.Bed removed from facility.

• Brand Name: CITADEL PLUS
• Type of Device: BARIATRIC BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH AB; 2349 w lake st suite 250; addison IL 60101
• MDR Report Key: 8416048
• MDR Text Key: 138660791
• Report Number: 8416048
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FX811B8B4AMABB
• Device Catalogue Number: FX811B8B4AMABB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Weight: 204