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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)

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

Event Date 12/08/2021

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 that the device posted a ventilator failure during use.The patient was then manually ventilated.No injury reported.

Manufacturer Narrative

The device was tested in follow-up of the event and did not exhibit any malfunctions.The log file indicates that the device passed the power-on self-test in the morning of the date of event without deviations.The concerned procedure was started in pressure mode and suffered from the beginning from an external leakage.Alarms of types fresh gas low or leak, apnea and p-insp not attained were posted.The user switched forth and back between different ventilation modes but this did not improve the situation; leaks of up to 3.9 l/min were measured.The fresh gas deficit persisted and led to a stalling of the ventilator piston at the upper end position, finally.The supervisor software forced a shutdown of automatic ventilation to protect from serious damages to the ventilator unit; a corresponding alarm was triggered.The procedure was continued for another 18 minutes in manual ventilation before the device was placed into standby.No indications for the potential presence of a device malfunction was found in the logs.Under normal conditions the ventilator piston operation leaves some volume reserve to equalize the effect of leakages.In particular, the piston movement is calculated in a way that a defined breathing stroke can be applied before the piston comes close to the upper end position.With a significant fresh gas deficit this reserve volume becomes smaller and smaller with every cycle until the full volume is moved out i.E.The piston reached the upper end position.If - like reported for this case - spontaneous breathing efforts of the patient occur simultaneously, the piston becomes stalled and the ventilator will be switched off for safety reasons.Dräger finally concludes that there is no issue with the device which would require repair or correction - the workstation shut down automatic ventilation as a safety measure to respond to a situation where a massive fresh gas deficit occurred in combination with spontaneous breathing efforts of the patient.The impairments of ventilation were brought to the user's attention by means of corresponding alarms before.But obviously the leakage was not removed and, the effects worsened until no volume reserve was left and the device reacted with a shutdown upon a stalled ventilator piston.

Event Description

It was reported that the device posted a ventilator failure during use.The patient was then manually ventilated.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.

Event Description

It was reported that the device posted a ventilator failure during use.The patient was then manually ventilated.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: 13051928
• MDR Text Key: 285394847
• Report Number: 9611500-2021-00523
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2010
• 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