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

Catalog Number 8603800

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device had a ventilator failure during use.There was no patient injury reported.

Manufacturer Narrative

The electronic log file indicates that the device passed the power-on self-test in the morning of the date of event w/o deviations.The particular procedure suffered right from the beginning from instable pressure conditions and fluctuating tidal volumes.Several alarms like pinsp not attained, apnea and fresh gas low / leakage were posted.After 8 minutes into the procedure the software detected a stalling of the ventilator piston due to a pressure peak in the range of 65 mbar.Consequently, a shutdown of automatic ventilation was forced which was brought to the user's attention by means of a corresponding alarm.Patient support was continued in manual ventilation for another nine minutes before the device was set to standby.No indications for a device malfunction was found in the logs.The unit was tested in follow-up of the event by a technician; no problems were detected either during the testing and the consecutive endurance run.Dräger finally concludes that the stop of ventilation was not related to a malfunction but furthermore the system's response to an external disturbance to protect from potential risks to the patient and to avoid damages of the ventilation unit.The exact root cause remains unknown; however - imaginable scenarios would be patient coughing, spontaneous breathing or chest movements caused by patient repositioning etc.There's no issue with the device that would require repair or correction.

Event Description

Please refer to initial mfr.Report #9611500-2019-00193.

• 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: 8747007
• MDR Text Key: 149780096
• Report Number: 9611500-2019-00193
• 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: 08/16/2019

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1