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

Catalog Number 8608500

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that during ventilation the device stopped accompanied by a "ventilator failure" alarm.Only man/spont possible.No patient injury reported.

Manufacturer Narrative

The responsible dräger service engineer could confirm the reported issue during on-site checking and trace it back to the ventilator motor.The entire motor assembly was replaced, consequently.The device was tested afterwards, found fully compliant to specification and could be returned to use.The replaced motor 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 to prevent from thee potential damages.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

Please refer to initial mfr.Report #9611500-2019-00011.

• Brand Name: PALLAS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8256215
• MDR Text Key: 133485009
• Report Number: 9611500-2019-00011
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• 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: 8608500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1