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

Model Number	9814DF101BCUSB
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was evaluated by a third party.The error code e102 was noted (a stable weight reading was not obtained).It has been concluded that the root cause of the bed exit alarm not working properly was due to the scale's inaccurate weighing.The alarm detects patient¿s movements, however it will not restrain the patient from leaving the bed.The circumstances of the patient¿s fall are not known.Instruction for use (ifu - 746-591-en) includes below information about patient fall risk: "to reduce the risk of injury due to falls, lower the bed to minimum height when the patient is unattended." ifu also states: "the patient movement detection function should be checked periodically for correct operation and before each new patient uses the bed." "before using patient movement detection, verify that the alarm can be easily heard by caregivers, e.G.At the nurse's station." the reported alarm malfunction did not lead to the patient's fall.The alarm detects patient's movementsm however, it will not restrain patient from leaving the bed.The root cause could not be confirmed.The circumstances of the event are not known, therefore it is unknown why the patient fell from the bed.To sum up, arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.The device did not meet specification as the alarm failure was observed.This complaint is reportable due to allegation of patient's fall from the bed resulting in a serious injury.
Event or Problem Description
Arjo was notified of an event involving an enterprise 9000x bed.It was reported that a bed exit alarm did not work properly, and the patient fell from the bed.As a result of the fall, the patient broke their hip.

• Brand Name: ENTERPRISE 9000X
• Common Device Name: 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 21617260
• Report Number: 3007420694-2025-00068
• Device Sequence Number: 6828325
• Product Code: FNL
• UDI-Device Identifier: 05055982755207
• UDI-Public: (01)05055982755207(11)181212
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 9814DF101BCUSB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown