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 10/15/2019

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 ventilator failure during use.There was no patient injury reported.

Event Description

Please refer to initial mfr.Report #(b)(4).

Manufacturer Narrative

The investigation was base on log file analysis.It could be determined that the automatic power-on self-test was performed in the early morning of the date of event and passed w/o deviations.The procedure in question was started in manual ventilation first and a few minutes later continued in volume mode.This sequence was stable and unremarkable.After one hour the user switched for the wake-up phase to pressure support mode.Seven minutes later the device detected pressure peaks; a pressure high alarm was posted, consequently.Other than reported the ventilation was not stopped but continued.After two minutes the device was placed into standby.There is no issue with the device that would require repair or correction.The instable pressure conditions that triggered the alarm were most likely cause by coughing during the revoking of spontaneous breathing in the phase of waking-up.

• 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: 9456499
• MDR Text Key: 179328586
• Report Number: 9611500-2019-00429
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1