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

Model Number	9814DF101BCUSB
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bed evaluation performed by an arjo service technician revealed damaged control module placed on the side rail.The up button was damaged (got stuck).It is unknown what caused the damage to the control panel module.The faulty side rail was replaced which solved the issue.The review of complaints and device inspection results indicates that the control panel button failure (stuck button) found during inspection might have led to the observed unexpected bed movement.The main factor that could lead to the button being stuck might be related excessive external force used.Since it is unknown what caused the damage to the control panel module, the root cause of the damage is impossible to confirm.The instructions for use for enterprise 9000x bed (746-591-en_11) includes the following information: ¿check that the patient controls, caregiver controls and attendant control panels operate correctly ¿ weekly.To sum up, the arjo device failed to meet its performance specification since the backrest was moving without any commands being given.There was no indication of the patient's involvement.This complaint is deemed reportable due to allegation of an unintended movement of the bed.
Event or Problem Description
Following the information gathered, there was an indication of an unintended movement on the enterprise 9000x bed.It was reported that the bed backrest was raising on its own.There was no indication that the bed was used with a patient.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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 20479867
• Report Number: 3007420694-2024-00258
• Device Sequence Number: 20831921
• Product Code: FNL
• UDI-Device Identifier: 05055982755207
• UDI-Public: (01)05055982755207(11)181022
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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
• Device Model Number: 9814DF101BCUSB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2018
• 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: Other
• Patient Sex: Unknown