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

Catalog Number 8603800

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that the device suddenly posted a vent fail alarm and suht down automatic ventilation.It was explicitly mentioned that the event did not lead to consequences for the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The evaluation and assessment was based on log file analysis.The entries stored therein confirm that the device has forced a safety shut-down of automatic ventilation due to an encoder check error of the motor/piston position.Evaluation of earlier reported similar events revealed that wear-and-tear related abrasion of the collector disc of the motor had resulted in development of positions where the motor does not provide mechanic power due to contact interrupts to the carbon brushes; speed fluctuations will be the consequence.The speed fluctuations result in a deviation between measured and expected piston position.The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.The motor is designed for a useful life of 10 years at typical operating conditions which would sum up to 13.000 operational hours.The particular device was in use for nearly 11 years with in total 16.150 operational hours which equals to 125% of the proposed life-time.It is thus seen likely that the aforementioned expertise from earlier investigations applies here as well.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.Other explanations such as issues with the position detection system may apply as well - an in-depth evaluation of the hardware was currently not done since an exchange of the entire ventilator unit may be uneconomic in reflection of the device age and, the customer has not decided upon a repair of the device yet.

Event Description

It was reported that the device suddenly posted a vent fail alarm and suht down automatic ventilation.It was explicitly mentioned that the event did not lead to consequences for the patient.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNIT
• 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: 18620856
• MDR Text Key: 334672438
• Report Number: 9611500-2024-00031
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: 01/15/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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