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

Catalog Number 8603800

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use a ventilator failure occurred.No injury reported.

Manufacturer Narrative

The affected device was tested and repaired on site by a field service technician - a printed circuit-board ("vgc analog 2" for processing of analog signals and actors and the encoder signals for ventilation control) has been exchanged and was sent together with the saved device log file to the manufacturer for investigation.The analysis of the device log file confirmed a problem with calibration data (pressure sensor) which has been detected during start up of the device, i.E.During pre-use check in the morning (without patient).According the log entries the issue was solved by calibration procedure (initiated by the user) and the device went into service, i.E.Use on a patient - the following log entries are unconspicous.The log entries does not confirm the initially reported ventilator fail during use on a patient.The exchanged pcb was tested for 7 days including multiple pre-use checks - the reported symptom could not be reproduced.Thus, the exact root cause for initially reported ventilator fail during use could not be determined.H3 other text: device checked and repaired on-site, log file and exchanged printed circuit board returned to manufacturer for investigation, exact root cause could not be determined.

Event Description

It was reported that during use a ventilator failure occurred.No injury reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 15010662
• MDR Text Key: 304455846
• Report Number: 9611500-2022-00168
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2019
• 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