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

Catalog Number MK06000

Device Problems Decrease in Pressure (1490); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported during a case that the unit was unable to build pressure.There was no patient injury reported.

Event Description

It was reported during a case that the unit was unable to build pressure.There was no patient injury reported.

Manufacturer Narrative

Based on the logfile analysis, the reported case could be reconstructed and no indications for a device malfunction were found.It was found that just from the beginning of the case, deviations between inspiratory and expiratory flow were detected, indicating a significant leakage in the patient circuit.Several apnea, minute volume low and fresh gas low or leakage alarms were given accordingly.During power-on self-test and leak test as well, internal and external leakages are detected.During use, based on leakage, fresh gas flow settings and set alarm limits, several audible and visible alarms would be issued, as it was also in this specific case, to indicate the disturbance of ventilation to the user.It can be finally concluded that the reported symptom was caused by a significant leakage in the patient circuit leading to a loss of pressure, volume and fresh gas.The device issues several alarms during the case to call the attention of the user.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10612037
• MDR Text Key: 209404616
• Report Number: 9611500-2020-00346
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• 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
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1