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); Failure to Deliver (2338); Reset Problem (3019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

It was reported that the screen went black and the device no longer delivered breaths.The patient was ventilated manually.There was no patient injury reported.

Manufacturer Narrative

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

Event Description

It was reported that the screen went black and the device no longer delivered breaths.The patient was ventilated manually.There was no patient injury reported.

Manufacturer Narrative

Based on a preliminary review of the device log file a replacement of the cf (compact flash) card and the pba therapy control unit was recommended.Both components were returned for investigation.The cf card was inserted to a lab device whereby the reported symptom could be reproduced.The precautionary replaced pba therapy control unit was also checked within a long-lasting test but did not reveal any abnormalities.If the pba therapy control unit no longer can access the cf card the device performs a reboot.The therapy is discontinued for a maximum of 16 seconds, before therapy will be resumed with the last valid settings.If the reboot is not successful an acoustical alarm will be given and a "system failure" message is posted as it could be confirmed for the case in question.Manual ventilation remains possible.Finally, it can be concluded that a faulty cf card was root cause of the reported symptom.The device has reacted as specified by posting corresponding alarms to inform the user about the situation.The faulty cf card was replaced and the device returned to use without further problems reported.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 ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 13964416
• MDR Text Key: 297319242
• Report Number: 9611500-2022-00082
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)220120(17)220430(93)MK06000-40
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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