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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Device Handling Problem (3265); Activation Failure (3270)

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

Event Date 06/28/2021

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 the perseus was in bypass mode and the user received a negative pressure and a vent fail message.No injury reported.

Manufacturer Narrative

Investigation was performed based on the device log analysis.The reported negative airway pressure followed by a ventilation failure could be retraced in the log.The device detected and alarmed the negative airway pressure below -10hpa, and opened the air entrainment valve as specified during the selected "pause" mode.Subsequently the device was switched to man/spont mode and 9 minutes later to standby.As in standby the air entrainment valve does not open and the pressure continuously dropped, finally a pressure of -60hpa was reached triggering a ventilator failure.It was reported that a nitric oxide therapy device was used.In this case no is added and simultaneously sample gas is taken to measure the no concentration.If gas sampling is continued by the no device even if the perseus is in pause mode or standby and no fresh gas is delivered, the system pressure will drop resulting in a vacuum.Therefore it can be concluded that the negative pressure was created by the pump of the connected no device and finally resulted in the reported ventilator failure, to prevent from damages to the system.Thus, if the investigation results had been available before, this case would not have been assessed as reportable.The use on an external sampling measurement device does not comply with the intended use.As no indication for a device failure could be found the reported symptom can be traced back to an application error.

Event Description

It was reported the perseus was in bypass mode and the user received a negative pressure and a vent fail message.No injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Not returned to manufacturer.

Event Description

It was reported the perseus was in bypass mode and the user received a negative pressure and a vent fail message.No injury reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESA 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: 12141411
• MDR Text Key: 262962045
• Report Number: 9611500-2021-00300
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)161111(17)170619(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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 07/08/2021; 07/08/2021
• Supplement Dates FDA Received: 09/07/2021; 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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