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 06/14/2023

Event Type  malfunction  

Event Description

It was reported that, when starting the induction of anesthesia to a pediatric patient, while ventilating with a mask, the equipment went into safety mode, indicating only manual ventilation was possible.No injury was reported.

Manufacturer Narrative

The investigation was started.The result will be forwarded in a follow up report.H3 other text : on-going.

Event Description

It was reported that, when starting the induction of anesthesia to a pediatric patient, while ventilating with a mask, the equipment went into safety mode, indicating only manual ventilation was possible.No injury was reported.

Manufacturer Narrative

For the investigation the provided logfile was analysed.On the reported date of event the device in question successfully passed the power-on self-test.The case in question was started using man/spont and continued using different automatic modes.Ventilation was widely unremarkable and stable.After changing to volume af mode after some hours of ventilation, the ventilator detected a wrong motor position and forced an autonomous shutdown to safety mode.As specified the ventilation mode was automatically changed to man/spont while the appropriate ventilator fail alarm was given.The user restarted the device and cancelled the following post.Therapy was continued without any further issues.The analysis of the device logfile revealed no indications for a general motor- or motor control problem.Most likely a kind of dirt either on the encoder wheel or inside the light barrier was disturbing the correct detection of the motor position.However the root for the reported ventilator failure can¿t be doubtless asserted.Dräger finally conlcudes that the device reacted as specified.The device autonomously changed to manual ventilation (man/spont).Manual ventilation remained unaffected, as specified.All alarms, possible causes and remedies are described in the instructions for 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.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17254560
• MDR Text Key: 318569678
• Report Number: 9611500-2023-00249
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2018
• 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
• Treatment: NA.; NA.