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

Catalog Number 8603800

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

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 ventilator failed during use.There was no injury reported.

Event Description

It was reported that the ventilator failed during use.There was no injury reported.

Manufacturer Narrative

Upon checking the log files the dispatched fse could confirm the observed shut-down of automatic ventilation.The engineer identified problems with the ventilator motor and replaced it, consequently.The device passed all consecutive tests and could be returned to use.Evaluation of the motor was not considered necessary since the phenomenon is known from earlier reports of the same nature.Wear-and-tear related abrasion of the collector disc may develop positions where the motor does not provide mechanic power due to contact interrupts to the carbon brushes.Speed fluctuations will be the consequence.Since the motor speed is being monitored continuously, the speed fluctuations result in a deviation between measured and expected piston position.To prevent from potentialy hazardous output and/or from damages to the ventilator unit the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component after 15 years of use.No patient consequences have been reported.The repair exchange has fully solved the device problem.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: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11278106
• MDR Text Key: 230230250
• Report Number: 9611500-2021-00046
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.