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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); No Pressure (2994); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an anesthesia the alarm "ventilator failure" was posted.No injury reported.

Event Description

It was reported that during an anesthesia the alarm "ventilator failure" was posted.No injury reported.

Manufacturer Narrative

The evaluation of the log file revealed that - during the concerned procedure - a sudden communication interrupt between the two processors of the board that controls the therapy functions has occurred.The device is designed to initiate a reboot to remove this error condition.The device will briefly power off and back on; the user will be alerted by means of a corresponding alarm.After the reboot which will typically be finished latest after 15 seconds the operation will be continued with the last valid settings.In the particular case the procedure was finished; the user has placed the unit into standby 43 minutes later.The therapy control board has been replaced as a precaution although it is seen likely that no hardware error has occurred.Finally - although it is evident that an internal communication problem with the particular pcb was the source of deviation - the triggering conditions remain unknown since log recording stopped with occurrence of the deviation.Dräger concludes that the device behaved as designed for such error condition - a reboot was triggered to resume therapy and the user was alerted to this condition by means of a corresponding alarm.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: 10746463
• MDR Text Key: 213439843
• Report Number: 9611500-2020-00379
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1