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

Catalog Number MK06000

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device switched off during use and it was not possible to turn it on again.It was further reported that the device went out but the alarm ¿no fresh gas delivery¿ was displayed.There was no patient injury reported.

Event Description

Please refer to initial mfr report no.9611500-2019-00203.

Manufacturer Narrative

The dispatched field service engineer determined that the sensor that monitors the central gas supply pressure was faulty.After its replacement the device was tested against full set of specifications and did not exhibit any further nonconformity.The finding of the on-site examination matches the description of the user.When the pressure sensor for the central gas supply fails the device alerts the user by means of the fresh gas delivery failure alarm that was reportedly observed.Furthermore, the graphical user interface will be covered by a message stating that gas delivery is stopped and that ventilation is still available.The virtual flow tubes are covered by a message explaining how to establish alternative fresh gas dosage using the safety o2 mechanism (switch from aux o2 to add o2 and open the valve).By following these steps the procedure can be continued with pure o2 fresh gas supply.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component.The user is being guided on the necessary steps how to continue the ventilation with a hand-adjusted safety flow of oxygen.

• 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: 8779465
• MDR Text Key: 150700502
• Report Number: 9611500-2019-00203
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1