MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Localized Skin Lesion (4542)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

Following the information provided the elderly patient fell from the bed and was found entrapped in the bed frame.The patient¿s right leg got trapped between the right bed rail and the metal frame of bed, under the mattress.Patient's head and left leg was on the floor.As the patient¿s upper half of their body was facing towards floor and somewhat under the bed, this position activated the bed¿s anti entrapment system (aes) safety feature.Staff were unable to disengage the aes system in order to extract the patient as they were unable to lower the bed or even raise it to free the patient¿s leg.The patient sustained minor injuries: bruising and small lesions.First aid was provided to the patient after the event.

Manufacturer Narrative

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

Event Description

Following the information provided the elderly patient fell from the bed and as a result became entrapped in the bed frame.The patient was found by the caregivers in the position with his right leg trapped between the right bed rail and the metal frame of bed, under the mattress.Patient's head and left leg was on the floor.As the patient¿s upper half of the body was facing towards floor and slightly under the bed, this position activated the bed¿s anti entrapment system (aes), which is a safety feature designed to prevent bed lowering movements when any obstacle is detected under the bed, to prevent crushing.Staff allegedly were unable to disengage the aes system and were not able to lower or raise the bed to free patient¿s leg.The patient was released with a support of four caregivers.The patient sustained minor injuries: bruising and small lesions.First aid was provided to the patient after the event.The injury was assessed by arjo clinical specialist as minor injury.The circumstances of the fall are unknown.The bed platform was flat prior to incident.Both top side rails and bottom left side rail were raised, while bottom right was lowered.The evaluation of the bed was not possible, as the customer did not make the bed available for evaluation.

Manufacturer Narrative

The root cause for the investigated patient fall cannot be determined due to lack of information about circumstances leading to fall and inability to evaluate the bed.The patient's entrapment was a direct consequence of a fall.Based on the collected information it was established that the anti-entrapment system (aes) worked as intended, preventing the bed movement from crashing the obstacle detected by the sensors (patient's leg in this case).Due to the fact that the evaluation of the bed was not possible, the reason for alleged inability to raise the bed remains unknown.The instructions for use for enterprise 9000x bed (746-591-en rev.15) includes the following information related to the investigated scenario: - "to reduce the risk of injury due to falls, lower the bed to minimum height when the patient is unattended", - "the anti-entrapment system is designed to detect the patient entrapment between the base and the mattress platform when the mattress platform is lowered, or is placed info tilt or auto-chair.The system is permanently active and cannot be switched off." - "if the beam is interrupted (e.G.By a patient's limb) while the mattress platform is lowering, the mattress platform stops moving and the weighing system display shows "aes".Upward movement of the mattress platform is not affected".Arjo device failed to meet its performance specification since it was not possible to lower or raise the bed.The device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of patient's fall from the bed, further resulting in entrapment.

• Brand Name: ENTERPRISE 9000X
• 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: 13534590
• MDR Text Key: 287584001
• Report Number: 3007420694-2022-00023
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 99 YR
• Patient Sex: Male