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

Model Number 8603800

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow-up-report.

Event Description

It was reported that the device posted a ventilator failure during use.There was patient injury reported.

Manufacturer Narrative

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 at 02:34 pm in pressure mode and suffered from the beginning from an external leakage.Alarms of types fresh gas low or leak and p-insp not attained were posted.A few minutes later the device detected a false piston position at the ventilator; the user changed to manual ventilation then.Another three minutes later the device was switched back to automatic ventilation.Shortly afterwards the next instance of wrong piston position was measured.At this point in time the piston was at the upper end position.Due to a stalled motor the supervisor software forced a shutdown of automatic ventilation to protect from serious damages to the ventilator unit.The procedure was continued for another 15 minutes in manual ventilation before the device was placed into standby.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 in 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

Please refer to initial mfr.Report #9611500-2020-00266.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNIT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10348813
• MDR Text Key: 203651846
• Report Number: 9611500-2020-00266
• 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
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8603800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1