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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress.The conclusions will be provided within follow-up report once the investigation is completed.
Event or Problem Description
Following the information provided the bed was intermittently lowering unintended, when the button was pressed, the bed did not stop moving once the button was released.The arjo engineer attended the bed for evaluation and repaired the bed by replacing the safety side with the built-in controllers.No patient was involved, no injury was sustained.
Event or Problem Description
Following the information provided the whole bed platform was intermittently lowering unintended.When the button on the control panel was pressed, the bed did not stop moving once the button was released.No patient was involved, no injury was sustained.The arjo engineer attended the bed for evaluation and repaired the bed by replacing the safety side with the built-in controllers and the bearing plates.The device was confirmed to be working in accordance to specifications after the repair.
Additional Manufacturer Narrative
Based on the available information the root cause of the complained scenario cannot be established.As per the information provided, since the bed would not stop lowering after releasing the control button, it is most likely that the issue was related with the failure of the button on control panel, which is built into the safety side of the bed.It is unknown what could have caused the malfunction of the part.The instructions for use for enterprise 9000x bed (746-591-en rev.12) includes the following information related to the subject of this investigation: - "it is recommended to use the function lockout facility on the attendant control panel to prevent unintended bed movement in situations where objects may press against the patient's controls." - "function lockout can be used to prevent operation of the controls, e.G.When inadvertent movement of the mattress platform could injure the patient." arjo device failed to meet its performance specification since it moved unintended.The device was not used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to unintended movement of the bed.

• 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: 14250314
• Report Number: 3007420694-2022-00058
• Device Sequence Number: 4887536
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190509
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• 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: Other
• Patient Sex: Unknown