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

Catalog Number MK06000

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

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 that the screen was frozen during a case.The patient had to be hand bagged.Reportedly no information about alarms.No patient injury reported.

Manufacturer Narrative

Front cover including touch panel have been replaced and forwarded to the manufacturer for investigation.The parts were installed into the periphery of a lab device.The reported malfunction could not be confirmed in a 7-days endurance run.There was no other information made available in regard to the course of event; an electronic log file was also not provided.The reported event of unresponsive touch screen could not be duplicated with the original parts.Consequently, a reliable conclusion in terms of root cause for the event can't be drawn.Since the parts were replaced in the particular device to enable investigation a potentially existing device problem was solved.In case of unresponsive touch screen an ongoing ventilation episode would be continued with the last valid settings.The user however may switch the device to standby mode, set oxygen and anesthetic agent flow manually and continue patient support with the integrated breathing bag.Monitoring functionality remains available as well.This is described in the ifu chapter "operation in case of emergency".

Event Description

Refer to initial mfr.Report #9611500-2017-00333.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 7013356
• MDR Text Key: 92756534
• Report Number: 9611500-2017-00333
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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