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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the available log file, the reported case could be reconstructed.It was found that during the case in question, a sporadic failure of the inspiratory pressure sensor of the vgc (ventilation and gas controller) was detected by the device.In consequence, the ventilator initiated an autonomous shutdown while changing mode (pressure mode) to man/spont accompanied by the corresponding "ventilator fail" alarm as specified.In this case, manual ventilation as well as monitoring function remains unaffected, the user continued ventilation in man/spont.One minute later the automatic ventilation was available again and the procedure was continued towards the end.Dräger finally concludes that the device reacted as specified upon a sporadic failure of the inspiratory pressure sensor.The device was tested according to manufacturers specification and returned into use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that a gas machine displayed a ventilator failure message on the screen in use on (b)(6) 2022 at 9:21am.The user was switching between volume mode and pressure mode at the time, in order to overcome some clinical messages the received.After bagging on manual mode for short time, the machine was switched back to volume mode without incient.No injury reported.

• Brand Name: PRIMUS
• 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: 14039797
• MDR Text Key: 297349290
• Report Number: 9611500-2022-00090
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K043607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2022

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: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2004
• 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