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

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 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Reportedly, the dispatched fse could narrow down the root cause to a problem with the ventilator motor and replaced it.The log files were checked by the manufacturer and, the reported issue as well as the validity of the on-site analysis can be confirmed.The log file indicates that the procedure in question went stable and unremarkable for more than two hours until the device detected a ventilator piston position error.The device alarmed and shut down automatic ventilation.The device was used for 4 more minutes in manual ventilation before it was switched to standby.The device is equipped with a piston ventilator which is driven by a stepper motor.The number of rotations forth and back is proportional to the piston hub and to the volume that will be shifted (tidal volume).The motor speed is being monitored continuously; speed fluctuations result in a deviation between measured and expected piston position.To prevent 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.No patient consequences have reportedly occurred.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component which is a wear-and-tear part and has lasted longer than the expected life time.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.

Event Description

It was reported that the device posted a ventilator failure during use.The users continued patient support in manual ventilation; no injury was reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNIT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10894343
• MDR Text Key: 217956487
• Report Number: 9611500-2020-00431
• 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
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• 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