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

Catalog Number 8603800

Device Problems Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

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 there was a vent fail during use.There was no patient injury reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

By means of the investigation of the description of event and the mentioned error codes, it was found that an overpressure at the patient end of the circuit led to a pressure peak.Based on the available information, it can be concluded that the device reacted as specified to an overpressure situation with an autonomous shutdown while changing mode to man/spont (safety mode) and generating the appropriate ventilator fail alarm.Manual ventilation remains possible in this case.Possibly, the patient was coughing at the time of event leading to the overpressure.Since neither the electronic device logfile nor further information was available for investigation, the exact root cause for the reported symptom could not be finally determined.Without the logfile, it was not possible to reconstruct the reported case either.The device in question was reportedly tested on-site, no malfunction was found, and the device was placed back into service without further problems reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 9314118
• MDR Text Key: 186752632
• Report Number: 9611500-2019-00381
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041436
• UDI-Public: (01)04048675041436(11)190116(17)190614(93)8603800-94
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1