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

Catalog Number 8603800

Device Problems Complete Blockage (1094); Gas Output Problem (1266); Failure to Sense (1559); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation has just started; an initial review of the anesthesia workstation's log file did not reveal any indication for the potential presence of a device malfunction.H3 other text : on-going.

Event Description

It was reported that the co2 trace got lost during a pediatric case and that a resuscitation was required.Actual patient status is unknown.

Manufacturer Narrative

The device was subject to a detailed on-site investigation performed by a dräger service engineer whereby no deviations from specification were determined.Log file review performed by the manufacturer revealed that the device was put into operation at 13:06 system time and passed the automatic power-on self-test a few minutes later without restrictions.The user entered patient data and started ventilation at 13:20 but for the next 12 minutes the flow monitoring of the device did not detect any volume shifting and alarmed for high airway pressure and low minute volume; no co2 values were recognized.At 13:32 the device detected a co2 trace with breathing phases and plausible values for pressure and flow but the co2 readings got lost again almost immediately.In the following, the readings for pressure and flow were fluctuating significantly which also caused unstable values for the derived parameter such as breathing frequency.The device posted alarms for co2 apnea as well as for mv low.At 13:53 the situation stabilized - the readings for pressure and flow were plausible with adequate values for etco2 and o2 uptake as well.The therapy was ended at 14:10 by putting the device into standby.The evaluation of device and log file data has not revealed any indications for the potential presence of a device malfunction and, it can further be concluded that adequate alarms have been posted to alert the user about the restrictions in ventilation.The most likely interpretation of the available information would be an obstruction in the pneumatic circuit outside the device or a stenosis.A differentiation is not possible; the user did not disclose the conditions that made the reported resuscitation necessary.

Event Description

It was reported that the co2 trace got lost during a pediatric case and that a resuscitation was required.Actual patient status is unknown.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17235580
• MDR Text Key: 318370058
• Report Number: 9611500-2023-00246
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2011
• 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
• Treatment: NA.; NA.
• Patient Outcome(s): Required Intervention