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

Catalog Number MK06000

Device Problems Inappropriate or Unexpected Reset (2959); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported that on (b)(6) 2019 at around 2pm a noticeable increase of the breathing rate was noticed.Subsequently, the screen was white and therefore no longer operable.The user then pressed the green on/off button and the device then returned to standby mode.From there, it was easy to switch back into a ventilation mode and to continue the ventilation without any problems.No injury reported.

Manufacturer Narrative

A similar error pattern has already been reported to us from the same hospital (kantonsspital graubünden).In this context, the affected device was investigated by the manufacturer and was basis for the investigation, in addition to the analysis of the devices log books and an assessment of the situation on-site.Based on the log analysis the occurrence of reboots could be comprehended.Before the reboots, there were indications of increasing processor utilization which may have resulted in a delayed display of real-time curves and therapy settings on the display, possibly causing a temporal compression of co2, pressure and flow curves, temporarily giving the impression of an increased breathing rate.The reported increased breathing rate may also have been caused by spontaneous breathing activities independently of the reported error pattern, since in autoflow the synchronization was switched on.During the on-site investigation, the reported failure reoccurred.It could be determined that a loose contact in the connection cable (not dräger) of the connected philips monitors was the cause of the failure.Further investigations were performed in the laboratory.It could be shown that the error mechanism could be provoked by a short-term interruption of the receiving line of the used cable.Therefore, it can be summarized that a faulty cable (connecting the philips monitors) was the root cause of the reported symptoms.As a remedy, the ribbon cables used by the customer were replaced by more robust round cables.

Event Description

Please refer to the initial report.

• 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: 9334049
• MDR Text Key: 178145383
• Report Number: 9611500-2019-00388
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170615(17)180203(93)MK06000-33
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• 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: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1