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

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Confusion/ Disorientation (2553)

Event Date 11/07/2021

Event Type  Injury  

Event Description

Following the information provided the bed was in lowest position, left side leg-end side rail was raised and the head-end side rail was lowered.The patient turned to the left side, but since the head-end side rail was lowered, the patient half fell from the bed because the body was not supported.The patient's weight was held by leg-end side rail.Due to patient's weight the lower side rail broke off and the patient fell out of bed.The patient was disoriented at the time of the fall.No injury was sustained.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

The evaluation of the bed performed by the arjo service technician confirmed that except for the detached side rail the bed was fully functional.The device was taken out of use after the event occurred.Based on the collected information it is concluded that the root cause of the investigated scenario is use error.The side rail gave away as a result of being loaded with the whole patient's body weight of 160 kg.It happened when the patient rolled back to the side, causing unintentional exit of the upper body part, which was not secured with the upper side rail.As a result the patient's body leaned on the lower side rail, which broke under load.The instructions for use for citadel (830.213-en rev.J) instructs the user as follows regarding usage of side rails and also takes into consideration the risk of patient's fall/inadvertent exit on several occasions: "whether and how to use side rails or restraints is a decision that should be based on each patient¿s needs and should be made by the patient and the patient¿s family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail/restraint use (including patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family.Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed."."to minimize the risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended." "specialty surfaces have different shear and support characteristics than conventional surfaces and may increase the risk of patient migration into hazardous positions of inadvertent bed exit.Monitor patients frequently to guard against patient entrapment." arjo device failed to meet its performance specification since the side rail detached.The device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to patient's fall resulting from safety side detachment.

Event Description

Following the information provided, the bed side rail detached.The bed was in lowest position, left side leg-end side rail was raised and the head-end side rail was lowered.The patient turned to the left side, but since the head-end side rail was lowered, the patient upper body half fell from the bed because the body was not supported.The patient's body was held by leg-end side rail.Due to patient's weight (160 kg) the lower side rail broke off and the patient fell out of bed.The patient was disoriented at the time of the fall.No injury was sustained.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 12948988
• MDR Text Key: 282282870
• Report Number: 3007420694-2021-00158
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 160 KG