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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that automatic was failing intermittently during use.There was no injury reported.

Manufacturer Narrative

Complaint (b)(4) is one out of 3 which were filed to document 3 events related to the same product problem with the same anesthesia workstation primus (serial number (b)(6).In all tree events the device posted a "check vent assebly" alarm.In such case, it cannot be excluded that ventilation is significantly disturbed, e.G.Due to a loss of airway pressure.A dröger service technician checked the device after the events.The electronic log file was downloaded and it yould be confirmed that there were intermittent issue related to the measured vacuum pressure which is needed to ensure proper function of the ventilator.Based on the log entries it was determined that a sporadic failure of the vacuum pressure sensor was the root cause for all 3 the reported events.In each case the primus has reacted as specified for this failure and posted a corresponding alarm.The sensor has already been replaced and the device has been operating without further issues since then.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that automatic was failing intermittently during use.There was no injury reported.

• 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: 16945495
• MDR Text Key: 315381955
• Report Number: 9611500-2023-00181
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041436
• UDI-Public: (01)04048675041436(11)170810(17)180107(93)8603800-93
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

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 Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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.