MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number MK06000

Device Problems Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the device alarmed for ventilator failure at the beginning of the surgical procedure.As per report, this did not lead to consequences for the patient.

Manufacturer Narrative

The electronic log file was evaluated by the manufacturer.The entries indicate that the device passed the system test prior to the concerned procedure without deviations.Ventilation was initially unremarkable and stable until the supervisor function detected a failure in the motor control signal.Automatic ventilation was shut-down to protect the patient from potentially hazardous output; the user was alerted to this by means of a corresponding alarm.The operator has continued to use the device for some minutes in manual ventilation and has then switched it to standby.The device was already involved in a similar event some months before.The motor control board was replaced; the device was functional afterwards.Evaluation of the motor control board in the manufacturer's lab after this first occurrence revealed a faulty component on it.Since the motor control board receives its entry information from another pcb which controls the therapy functions, it was decided to additionally replace the therapy control unit after the second instance of the fault.The original therapy control unit was subject to a two-months test in the manufacturer's lab with varying settings but did not exhibit any malfunctions.Hence, it can be excluded as the causer of the ventilator failure.But finally, the exact root cause that led to the deviation in the motor control signal could not be determined.As confirmed for the particular case - if automatic ventilation is shut down for safety reasons, monitoring functionalities and manual ventilation remain available.

Event Description

It was reported that the device alarmed for ventilator failure at the beginning of the surgical procedure.As per report, this did not lead to consequences for the patient.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16214084
• MDR Text Key: 309075570
• Report Number: 9611500-2023-00018
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170906(17)180419(93)MK06000-34
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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