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)
Type of Reportable Event	Malfunction
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 customer complained that the unit needed service.The arjo technician attended site to evaluate the bed and determined that the side rail lower arm was detached from its mounting points.There is no indication of patient involvement.No injury was sustained.
Additional Manufacturer Narrative
Following the information provided the customer complained that the bed needed service as the side rail did not work.The arjo technician attended site to evaluate the bed and determined that the side rail lower arm was detached from its mounting points.No patient was involved and no injury occurred.There are no details about the circumstances of damage available.An arjo service technician suspected that the bed could have been hit during the use by e.G.Door or a wall the review of post-market surveillance data and the investigation carried out at the manufacturer site 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 would be in line with the arjo technician¿s assessment.The instructions for use for enterprise 9000x (746-591-en rev.15) includes the instructions for safe operation to avoid damage of the bed as follows: "when the bed is operated, make sure that obstacles such as feet, oxygen bottles, beside furniture or any other objects do not restrict its movement." "hold the head board or foot board when pushing or pulling the bed; do not hold the side rails or any attached accessories." "check operation of split side rails daily." arjo device failed to meet its performance specification since the side rail lower arm detached.The bed was not used for patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of safety side partial detachment (lower arm insecure).

• 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: 15507581
• Report Number: 3007420694-2022-00158
• Device Sequence Number: 17453675
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190305
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2022

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
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2019
• 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