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

Model Number FX811B3B4AMABB

Device Problem Human Factors Issue (2948)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2018 arjohuntleigh was notified about a complaint involving citadel plus bed.The reported incident took place in (b)(6).(b)(6) medical center in the united states.Following the information reported the patient fell out of the bed.According to nurse at the time the incident occurred the patient was trying to get up from bed leaning on the safety side.As a result of patient putting all of his weight on the safety side one of safety side bolts became loose.It caused the safety side to lower down and led to the patient's fall.There was no injury nor other medical consequences reported.It needs to be emphasized that the citadel plus bed are dedicated to the patient's weighing up to (b)(4).The patient putting all of his weight on the safety side may cause it's physical damage, although the safety sides itself are not intended to be used as a support lever.All manufactured citadel plus beds are checked before being distributed to the customers to verify if the product meets the required manufacturer's specifications and check whether the acceptance criteria are met.Records of the inspection are documented in the device history record (dhr).The device history record has been reviewed for this specific device and no anomaly was found.The device involved in the event is part of arjohuntleigh us rental fleet.Each rental device before being released for next rent must pass a quality control check.The pre use check did not reveal any device malfunction.After the incident the functionality of the bed was verified by the arjohuntleigh technician.The evaluation confirmed that the safety side was physically damaged.In arjohuntleigh technician opinion such a malfunction could occur only due to an excessive force being applied on a safety side.The product instruction for use (#831.374 rev.B dated on dec-2015) which was supplied together with the involved device contains all crucial information and warnings which should be followed to ensure patient safety: "to minimize the risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended", "(.) caregivers should assess risk and benefits of side rail use (including the entrapment an patient fall from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family." -"caregivers should always aid the patient in exiting the bed.Make sure a capable patient knows how to get out of bed safely (.) " summarizing, upon the conducted investigation and bed inspection done by the arjohuntleigh representative, we were able to determine that the patient's fall occurred due to safety side unexpected collapse under the force exerted by the patient.Although there was no injury sustained the complaint was decided to be reportable due to the allegation of patient's fall.The device was being used for patient care at the time of the incident.The safety side was reported to become damaged and from that perspective the citadel plus bed did not meet the manufacturer's specification.

Event Description

On (b)(6) 2018 arjohuntleigh was notified about a complaint involving citadel plus bed.The reported incident took place in (b)(6).(b)(6) medical center in the united states.Following the information reported the patient fell out of the bed.According to nurse at the time the incident occurred the patient was trying to get up from bed leaning on the safety side.There was no injury nor other medical consequences reported.

Manufacturer Narrative

Missing udi number was added.

• Brand Name: CITADEL PLUS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7372706
• MDR Text Key: 103945737
• Report Number: 3007420694-2018-00071
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2018
• Distributor Facility Aware Date: 03/07/2018
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 04/23/2018
• Date Manufacturer Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 181