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

Catalog Number 8607500

Device Problems Degraded (1153); Gas Output Problem (1266); Inaccurate Delivery (2339)

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

Event Date 07/27/2023

Event Type  malfunction  

Event Description

It was reported that during use the error message "respiratory failure" was posted.No injury reported.

Manufacturer Narrative

It was reported that during on-site inspection a faulty motor was identified as cause for the reported symptom.As no device log file was available for investigation only a general evaluation of the case in question is possible.In case of a ventilator failure the device will force a shutdown of automatic ventilation which is accompanied by a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.After replacement of the motor assembly the device was successully tested and was returned to use.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component; no patient consequences have been reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.H3 other text : device not available for investigation, 3rd party service.

• Brand Name: PRIMUS IE
• 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: 18353681
• MDR Text Key: 331191443
• Report Number: 9611500-2023-00489
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675224747
• UDI-Public: (01)04048675224747(11)190805(17)240227(93)8607500-53
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2023

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: 8607500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2015
• 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