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	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was informed about broken side rail from enterprise 9000x bed.The device was inspected by an arjo service technician.It was clarified that side rail lower arm was ripped off from the bed frame.It was suggested by the arjo service technician that the side rail was damaged by a mentally ill patient.Arjo received in total 3 complaints from the same customer with the same malfunction (b)(6); 3007420694-2024-00314, (b)(6); 3007420694-2024-00315 and (b)(6); 3007420694-2024-00321).This report refers to (b)(6); (3007420694-2024-00321).
Additional Manufacturer Narrative
According to the arjo service technician, more than one bed was damaged in the same way and the damage to the side rail was most likely intentional.The device was taken out of use.The customer didn't want repair at this time.The review of post-market surveillance data revealed that the main factor which could lead to the side rail detachment might be related to an excessive force applied to the side rail.This is in line with the information received and the bed frame condition.Arjo device did not fail to meet its performance specification since the side rail lower arm was most likely intentionally ripped out by a patient.There was no injury reported.The complaint was assessed as reportable due to the side rail detachment.

• 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: 20901128
• Report Number: 3007420694-2024-00321
• Device Sequence Number: 18405252
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190404
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 12/11/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2019
• 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