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	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Following the information provided, there was an indication of an unintended movement on the enterprise 9000x bed.It was reported that the bed ¿keeps elevating uncontrollably and stops working¿ and that the codes e410 and e300 were displayed on the bed.There was no indication of a patient involvement.No injury was sustained.
Additional Manufacturer Narrative
The device was inspected by arjo representative.During inspection it was found that the button, located on the side rail control panel, was stuck in an activated position.It was detected by the bed as the e300 and e410 error codes displayed by the device.The troubleshooting section in the device technical documentation implies that whether the error code e300 is displayed on the control panel, the control button was pressed for more than 90 seconds.The instructions for use for the enterprise 9000x (document number: (b)(4)) includes the following information related to error codes e300, e410 and the maintenance of control buttons: ¿if a button is held down for more than 90 seconds, the function will be automatically inhibited until the button is released.Remove pressure from control button.If error code does not clear call an arjo-approved service agent.E410 ¿ service error.Call an arjo-approved service agent.Check that the patient controls, caregiver controls and attendant control panels operate correctly ¿ weekly¿.Based on the above, the e300 and e410 error codes were displayed because the control button was stuck in activated position, which led to unintended movement of the bed.To sum up, there is no indication that the device was used with a patient when the event occurred.The device failed to meet its performance specification since there was a damaged control button which resulted in an unintended movement.The complaint was decided to be reportable due to allegation of an unintended bed movement.No injury was reported.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17161351
• Report Number: 3007420694-2023-00144
• Device Sequence Number: 5818675
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190405(21P0541985
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/20/2023

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: 06/01/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• 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