MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 8000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 8X23PL103DBABA

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

Following the information provided the customer alleged that the bed backrest actuator raised on its own.The arjo technician attended the customer's site for inspection of the bed.The complained issue was not witnessed by the technician, however he determined that the attendant control panels were defective.The technician repaired the bed by replacing faulty parts.At the time of event the patient was on the bed.No injury was sustained.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

Based on the post-market surveillance data and an arjo service technician assessment, the most likely cause of the reported unintended movement may have been the attendant control panel failure.The acp control panels, located on the outside panels of both foot end side rails, provide full control of all the bed¿s functions.The arjo technician replaced the acp control unit and other parts were fitted, and the bed was working as intended.Although it was not possible to confirm the reported issue, the service technician indicated that the most likely cause of the malfunction may have been a defective acp control unit, however based on the information gathered, the exact cause of the malfunction could not be determined.The instruction for use for the enterprise 8000x (document number: (b)(4) includes the following information related to handling of the acp control unit: ¿check that the (¿) attendant control panels operate correctly¿ - this activity is to be done by qualified personnel weekly during preventive maintenance procedures.To sum up, the bed did not meet its performance specifications due to unintended movement of the backrest section.The device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of unintended movement of the backrest actuator while in use with patient.

Event Description

Following the information provided, there was an unintended movement of the enterprise 8000x bed backrest actuator, while being in use with a patient.No injury was sustained.There was an allegation from the customer that the chest actuator raised on its own.An arjo service technician performed an evaluation of the bed and assessed, by its visual condition, that the gas spring was overused.The bed was repaired (the gas spring, the acp control unit from 2 side rails, and the battery box were replaced).

• Brand Name: ENTERPRISE 8000X
• Type of Device: 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: 16033008
• MDR Text Key: 306177507
• Report Number: 3007420694-2022-00231
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2023

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 Operator: Other
• Device Model Number: 8X23PL103DBABA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other