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	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Following the information provided the customer reported intermittent functioning of one of the control panel buttons on enterprise 9000x right body side rail.Upon evaluation the arjo technician confirmed that the button on the control panel was faulty and when the button was released, the bed continued to move intermittently.There is no indication of patient involvement.No injury was sustained.
Additional Manufacturer Narrative
The investigation is in progress.Conclusions will be provided within the follow-up report once the investigation is completed.
Additional Manufacturer Narrative
Based on all collected information and results of evaluation performed by arjo technician the most likely root cause of an intermittent unintended movement of the bed was damage of the control panel hi-lo button, originating from the collisions with objects, such as door frames, during maneuvering of the bed.The technician observed blemishes at the control panel button membrane which seems likely to have weakened the button, so that it did not spring back to its neutral position at times.The instructions for use for enterprise 9000x (746-591-en) include the following information related to the investigated scenario: "the controls require only a single press to activate.To prevent unwanted movement of the mattress platform, avoid leaning against the split side rails and keep equipment on and around the bed clear of the controls" "check that the patient controls, caregiver controls and attendant control panels operate correctly" - this is a preventive maintenance activity that is to be performed weekly by the caregiver.Arjo device failed to meet its performance specification since the control panel was damaged and caused an intermittent unintended movement.There is no indication of usage of the device for a patient treatment when the failure occurred.This complaint is deemed reportable due to allegation of an unintended movement of the device.
Event or Problem Description
Following the information provided the customer reported intermittent functioning of one of the control panel buttons on enterprise 9000x right body side rail.Upon evaluation the arjo technician confirmed that the hi-lo button on the control panel was faulty.After intentional activating the movement by the operator, when the button was released, the bed did not stop moving but continued to move.The issue was not consistent, but it was witnessed.No patient was involved when the failure occurred.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: 15416705
• Report Number: 3007420694-2022-00148
• Device Sequence Number: 12414581
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190220
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 08/18/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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