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	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device inspection performed by the arjo representative after the event did not allow to recreate the complained malfunction.The device was working as intended.The enterprise 5000x bed passed the functional test and the device was released for use.As per the arjo representative's assumptions, the control panel button may have been accidentally pressed when a person leaned over the side rail to attend the patient, resulting in movement of the bed.This is an assumption based on the similar historical claims raised by this customer, however this scenario cannot be confirmed.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 the bed moved unintended.The device was not used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of an unintended movement.
Event or Problem Description
Following the information provided the customer complained that the bed was going up and down on its own.No patient was involved, no injury was sustained.

• 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: 14520946
• Report Number: 3007420694-2022-00082
• Device Sequence Number: 20205675
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190429
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/27/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2019
• 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