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

Catalog Number 8603800

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that during a case the primus has posted a ventilator failure.No patient injury was reported.

Manufacturer Narrative

During the first on-site log analysis, an error entry regarding the ventilator motor was found.A device self-test was performed.In addition, various modes of ventilation were tested.The primus and its ventilator in particular worked flawlessly.Due to the logbook entry, the motor was replaced as a precautionary measure and sent in together with the electronic logbook for further analysis.The case in question could be reconstructed by means of the information recorded in the log file.The affected device was turned on at 7:10am on the day of the event and passed the device self-test without error.The case in question was started at 10:54am in man / spont.About a minute later, the user activated the pressure mode.At 11:10am the primus detected a pressure peak and generated an audible and visible aw.Pressure high and a pressure negative alarm.In parallel it recorded 2 encoder check errors which indicate that the expected position of the ventilator piston deviated from that actually detected.The primus has responded as specified for this case, interrupted automatic ventilation and displayed an audible and visible ventilator fail alarm.In this case, the user still has the option of manual ventilation with 100% o2 and anesthetic gas.The examination of the returned ventilator motor has revealed any failure, which goes along with the reported information, that after the incident on site both self-test and also ventilation functioned.It can be concluded that the logbook entries were not the result of a technical error.Apparently, there was a pressure peak (for example, due to movement of the patient) during ventilation, which had affected the movement of the ventilator piston and eventually to the above-mentioned deviations in the position detection.

Event Description

Please refer to the initial-report.

• 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: 7950762
• MDR Text Key: 123371935
• Report Number: 9611500-2018-00325
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041436
• UDI-Public: (01)04048675041436(11)160307(93)8603800-89
• 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: 11/15/2018

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: 09/14/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1