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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The safety side rails are an integral part of the enterprise 9000x bed frame.This bed has four side rails, two on each side of the bed.Following the information received, the arjo service technician found that the pivot pin of the side rail was missing, causing the side panel to detach from the bed frame.The circumstances in which the safety rail was damaged are unknown.The device was repaired.The instructions for use for enterprise 9000x (ifu, 746-591-en) include a preventive maintenance activity to be performed daily by the caregiver: "check operation of split side rails".Based on the information received, the exact cause of the reported safety side rail failure could not be determined.Arjo device failed to meet its performance specification since the side rail panel detached partially from the side rail mechanism.The complaint was assessed as reportable due to the partial side rail detachment (pivot pin missing).There was no allegation of any patient involvement.No injury was reported.
Event or Problem Description
Arjo received a customer complaint for enterprise 9000x bed.Following the information provided enterprise 9000x bed was found with damaged side rail.Based on the information received from an arjo service technician, the side rail detached partially from the bed frame due to a missing pivot pin.No patient involvement was reported.No injuries occurred.

• 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: 18099614
• Report Number: 3007420694-2023-00268
• Device Sequence Number: 18050651
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190315
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

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
• Device Model Number: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2019
• 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