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

Catalog Number 8606500

Device Problems Unexpected Therapeutic Results (1631); Failure to Deliver (2338); Device-Device Incompatibility (2919)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported that during a case the ventilator showed a ventilator failure and only manual ventilation was possible.No injury reported.

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.H3 other text : on-going.

Manufacturer Narrative

The device was subject to an on-site evaluation performed by a dräger service engineer.It was not possible to reproduce the reported failure.The device was tested and confirmed to be operating per manufacturer's specifications.Log file evaluation revealed no indications for a technical malfunction.It was found that during the procedure negative airway pressures were present.The negative airway pressures in combination with the detected fresh gas deficit are typically for the usage of a suction system while the patient remained connected to the breathing system.Due to the resulting vacuum pressure the piston motor got stucked.As a consequence the ventilator initiated an autonomous shutdown while changing mode to man/spont and generating the appropriate ventilator fail alarm.Manual ventilation remains possible in this case.The instructions for use describes as a warning to disconnect the patient from the ventilator prior to the use of a suction unit and that if not used correctly, the suction unit may injure the patient.Therefore, it can be concluded that the reported issue was caused by user error not following the instructions for use.The device has reacted as specified for the detected situation.Finally, the device was tested and returned to use without further problems reported.

Event Description

It was reported that during a case the ventilator showed a ventilator failure and only manual ventilation was possible.No injury reported.

• 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: 19163829
• MDR Text Key: 340827093
• Report Number: 9611500-2024-00175
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 05/24/2024

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: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2009
• 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