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

Model Number	9614DF101BCUSB
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.The conclusions will be provided within the follow-up report, once the investigation is completed.
Event or Problem Description
Following the information provided, the backrest of the bed was articulating on its own at times.There was no patient involved when the malfunction occurred.No injury was sustained.The evaluation of the bed performed by the arjo engineer allowed to determine that the controller and its cables were worn as a result of coming into contact with the patient's wheelchair during transition in and out of bed.After continuous use this way, the parts became excessively worn out.
Additional Manufacturer Narrative
It was confirmed that the device was not serviced by arjo until the complained event, when the repair was performed as a result of the investigated complaint.The arjo engineer repaired the bed by replacing the faulty control panels and a side rail.Based on the collected information it can be concluded that the root cause of the complained event is excessive wear of the components due to use error.The control panel became prematurely worn as a result of continuous contact with the patient's wheelchair during each transfer.It is also unknown whether the device was maintained at all, there is no record of service and maintenance activities.The ifu for enterprise 9000x bed (746_594-am rev.9) includes the following information relevant to the subject of this investigation: "it is recommended to use the function lockout facility on the attendant control panel to prevent unintended movement in situations where objects may press against the patient's controls"; "check that the patient controls, caregiver controls and attendant control panels operate correctly"; this maintenance activity is to be performed weekly by the caregiver.Arjo device failed to meet its performance specification since the malfunction of control panels and cable resulted in unintended movement of the bed.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 of the backrest.
Event or Problem Description
Following the information provided the customer stated that the bed moved unintended, without any commands given.The customer reported the issue to arjo and requested for repair.No patient was involved at the time of the event.No injury was sustained.The arjo engineer who performed an evaluation determined that the head and foot right safety rails had damaged control panels and cables, which resulted in unintended backrest movements at times.Engineer observed that the patient wheelchair comes into contact with the control panels every time the patient transfers himself in and out of the bed, that way leading to control panel and cables damage.

• 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: 12827501
• Report Number: 3007420694-2021-00149
• Device Sequence Number: 19202802
• Product Code: FNL
• UDI-Device Identifier: 05056097337265
• UDI-Public: (01)05056097337265(11)180312
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/16/2021

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: Lay User/Patient
• Device Model Number: 9614DF101BCUSB
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2018
• 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