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

Catalog Number MK06000

Device Problem Gas/Air Leak (2946)

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

Event Date 04/02/2024

Event Type  malfunction  

Event Description

It was reported that the perseus anesthesia "workstation" generated alarms indicating a leakage and started "emergency air mode".Based on what was reported, the users continued to ventilate the patient with an external emergency breathing bag because obviously ventilation wasn't possible at all.No injury reported.

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow-up-report.H3 other text : on-going.

Manufacturer Narrative

The electronic device logfile was analyzed for the reported date of event march 21st 2024.The case in question was started at 12:44 using man/spont and continued in volume control af from 12:51.Just from the beginning the device alarmed repeatedly inspiratory tidal volume high, minute volume low, fresh gas low or leakage and emergency air inlet activated indicating a circuit leak.The user switched back and forth between man/spont and volume control af without any improvement of ventilation.At 13:23 the unit was placed in standby.The analysis of the device logfile has given no hints for a malfunction of the device.The reported symptom was caused by a significant circuit leak leading to a loss of pressure, volume and fresh gas.The device issued several alarms to call the attention of the user.Based on the investigation results the impairment of ventilation was caused by an external leakage in the breathing circuit and was not caused by a technical device malfunction.Therefore, the case was assessed as non-reportable in retrospect.

Event Description

It was reported that the perseus anesthesia worstation generated alarms indicating a leakage and started "emergency air mode".Based on what was reported, the users continued to ventilate the patient with an external emergency breathing bag because obviously ventilation wasn't possible at all.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: 19163831
• MDR Text Key: 340827069
• Report Number: 9611500-2024-00174
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

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: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2014
• 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