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

Catalog Number MK06000

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver (2338); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during a case that the unit posted a vent failure alarm.There was no patient injury reported.

Manufacturer Narrative

Preliminary review of the logs led to the conclusion that the pba a500 blower and the blower unit m3 needed to be replaced.The replaced parts and the electronic log file were submitted for further analysis.The returned components were assembled in a lab device.Within a 7 days test run using different modes and settings and incl.A daily system test, the reported symptom couldn¿t be reproduced.However, the case in question could be reconstructed by means of the information stored in the electronic log file.At 1:46pm on the reported date of event, the perseus a500 detected an unexpected deviation within the blower control.A corresponding visible and audible torbovent 2 failure alarm was generated.In case of such failure fresh gas delivery will be continued and manual ventilation remains available to continue the case.The relevant parts were replaced.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 9465297
• MDR Text Key: 186751884
• Report Number: 9611500-2019-00436
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)190116(17)190902(93)MK06000-35
• 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: 02/10/2020

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
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1