MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 5000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number UNKNOWN

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Event Description

Following the information provided, the wardsperson was removing a bed with electric drive (indigo module - intuitive drive assist) from the theatre to its designated area after a patient was transferred to the theatre.The operator was walking towards the exit and stopped to speak to a colleague (theatre wardsperson) and had hands completely off the bed.The indigo module was not disengaged and brakes were not applied at that time.Then the indigo module activated itself and the bed came back towards the bed operator in full motion.The operator stated as follows: ¿i had to brace myself to be able to bring the bed under control and to a stop¿.No patient was involved at that time.No injury was sustained.

Manufacturer Narrative

Based on the collected information it was not possible to determine the root cause of the alleged unintended indigo module activation.The evaluation of the involved device could not be performed by arjo because the facility did not report this event to arjo at the time of the incident, moreover, after the event, the facility removed all enterprise beds with indigo from service and therefore it was not possible to identify the bed involved in the complained event.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 device allegedly activated unintended.The device was not used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of an unintended activation and movement of the indigo module of the bed.Device not available for evaluation.

• Brand Name: ENTERPRISE 5000X
• 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: 15885718
• MDR Text Key: 307588805
• Report Number: 3007420694-2022-00198
• Device Sequence Number: 1
• Product Code: FNL
• 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: Other
• Type of Report: Initial
• Report Date: 11/30/2022

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 Operator: Other
• Device Model Number: UNKNOWN
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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