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

Catalog Number 8603800

Device Problem Output below Specifications (3004)

Patient Problem Coma (2417)

Event Date 07/20/2019

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that the device has not delivered sufficient minute volume.Patient is currently in a coma.

Event Description

Please refer to initial mfr.Report #9611500-2019-00222.

Manufacturer Narrative

The workstation was tested on-site in follow up of the event - no deviations from specification were detected.The log file could be evaluated by the manufacturer.It turned out that the procedure in question was suffering since the beginning of automatic ventilation from restrictions in gas flow.The adjusted airway pressure limit was repeatedly exceeded before the whole tidal volume could be applied; individual breathing strokes were thus aborted to protect the patient from overpressure.The corresponding alarms pressure limitation, tidal volume not attained and minute volume low were posted.As a consequence of insufficient ventilation the etco2 readings went up to 99mmhg which triggered the etco2 high alarm.The patient was ventilated in manual ventilation mode which improved the situation - the airway pressure limit was still reached but the applied tidal volumes increased to values above 500ml.The measured co2 declined to 40mmhg in the following towards the end of the procedure.The log does not contain any hint for the potential presence of a device failure; the tests done in follow-up of the event substantiate that.The ventilator was able to build-up airway pressure at any time.The restrictions in ventilation were detected, countermeasures were initiated and appropriate alarms have been posted.All alarms, potential root causes and dedicated remedies are explained in detail in the ifu.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8849526
• MDR Text Key: 152902938
• Report Number: 9611500-2019-00222
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.