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

Model Number 8X34G4113DBAFB

Device Problems Unintended Movement (3026); Activation Problem (4042)

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

Following the information provided the operator moved the bed out of the room with indigo module (intuitive drive assist) activated, to make space for an incoming patient.She then deactivated the indigo and stopped the bed.When she came back to the bed, the operator reactivated the indigo and proceeded to push the bed down the corridor.Whilst pushing the bed, it suddenly stopped (braked), with indigo still engaged.The operator waited a second before continuing to move the bed, but before she managed to put her hands back on the bed, the bed took off by itself from stationary position.After travelling circa 5 meters, the operator managed to stop the bed by using emergency stop button.The device was disengaged and taken out of use.No patient was involved, 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

The manufacturer's investigation is in progress.Faulty part was requested for return for investigation and the determination of availability is in progress.The conclusions will be provided within the follow up report once available, within the required deadline.

Manufacturer Narrative

The manufacturer's investigation is in progress.It was confirmed that the allegedly faulty pcb is available and it will be returned to the manufacturer.The conclusions will be provided within the follow up report once available, within the required deadline.

Manufacturer Narrative

Arjo became aware of the event involving the enterprise 800x bed equipped with the indigo module (intuitive drive assist).Following the information reported, the bed was pushed by the nurse down the corridor whilst it suddenly stopped (braked), with indigo still engaged.Before the nurse managed to put her hands back on the bed, the bed allegedly moved forward by itself.After traveling about 5 meters, the operator stopped the bed by using the emergency stop button.The device was disengaged and taken out of use.No patient was involved, no injury was sustained.Based on the collected information, the service technician who inspected the bed directly following the event was not able to duplicate the claimed issue (no unintended movement of the bed was observed).The pcb¿s leds showed a fault with the accelerometer (part of the pcb), therefore, the technician changed the pcb.The faulty pcb returned from the market was evaluated by arjo electronic engineer.The bed rapidly braked when the bed was moved with the activated indigo as it was claimed by the nurse.It was caused by the fault of the software installed on the pcb.After re-upload the software, the problem did not reoccur.The engineer observed also that the bed accelerated when it was pushed.The indigo module did not move without any intentional activation from the stationary position.Acceleration was caused by the gyroscope (pcb assembly component) measurement errors.Due to the incorrect angle calculation, the device read as if it drove up the slope and powers the indigo wheel according to that state while being on a flat surface.The instructions for use (ifu) for indigo module (416260-en) includes the following information regarding the correct operation of the module: - "when operating indigo, maintain contact with bed at all times" - "after using indigo: deactivate indigo and apply brakes by placing the pedal in the most downward position".Arjo device failed to meet its performance specification since the pcb malfunction resulted in the alleged unintended movement of the bed.The device was not used for patient treatment when the malfunction occurred.This complaint is deemed reportable due to an allegation of the unintended movement of the bed equipped with indigo module.

Event Description

Arjo became aware of the event involving the enterprise 800x bed equipped with the indigo module (intuitive drive assist).Following the information reported, the bed was pushed by the nurse down the corridor whilst it suddenly stopped (braked), with indigo still engaged.Before the nurse managed to put her hands back on the bed, the bed allegedly moved forward by itself.After traveling about 5 meters, the operator stopped the bed by using the emergency stop button.The device was disengaged and taken out of use.No patient was involved, no injury was sustained.

• 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: 15958331
• MDR Text Key: 307729961
• Report Number: 3007420694-2022-00205
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097359465
• UDI-Public: (01)05056097359465(11)210323
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8X34G4113DBAFB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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