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

Catalog Number 8603800

Device Problems Device Alarm System (1012); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation of the available information and the logfile analysis, the reported issue could be confirmed and traced back to the ventilator motor.The entire motor assembly was replaced by dispatched fse consequently and was subject to in-depth evaluation in the manufacturer's lab.The motor started rotation normally but there were several positions found at the collector where the electrical contact to the carbon brushes gets interrupted.This causes fluctuations in the rotation speed that will be detected by the supervisor function of the software.If two or more consecutive deviations occur within a specified time period the software forces a shutdown of automatic ventilation.Dräger finally concludes that the workstation responded as designed upon a wear-and-tear related malfunction of a single component.Speed fluctuations at a piston ventilator motor may result in deviations between expected and real piston position and, significant mechanical damages to the ventilator system may occur as a consequences.If the defined trigger criteria are met, the supervisor function forces a shutdown of automatic ventilation.The user is made aware of that by means of a corresponding alarm.Manual ventilation with the built-in breathing bag remains possible; the monitoring functionalities will still be available as well.No patient consequences have occurred in the particular case.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the device suddenly alarmed for ventilator failure while being used on a patient and stopped automatic ventilation.The patient support was bridged with a transport ventilator.There was no detail in the report which would reasonably suggest that patient consequences might have occurred.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 8895996
• MDR Text Key: 154549509
• Report Number: 9611500-2019-00246
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2019

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: No
• 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