MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA; VENTILATORS, INTENSIVE CARE

Device Problems Gas Output Problem (1266); Device Emits Odor (1425); Failure to Deliver (2338); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.We will provide results in a separate follow-up-report.

Event Description

It was reported that the device posted a device failure ¿42.000¿ during use.In addition the user noticed a burning odor.There was no injury reported.

Manufacturer Narrative

The given failure code indicates a problem with the turbine speed.A detected temporary minor deviation in turbine speed doesn¿t have an effect as long as patient pressure and flow are within the tolerance range.In case a reduced turbine speed affects patient ventilation alarms like ¿airway pressure low¿ or ¿tidal volume low¿ are posted in parallel or ventilation is completely switched off.In any case high priority alarms alert the user and the device has to be replaced.The turbine and the motor controller board were returned for evaluation.Both show a total damage which is, based on experience, only explainable if the supply voltage lines are reversely connected.It can be excluded that this may occur ad hoc during use.Furthermore, the motor has a production date 04/2018 while reportedly the last motor replacement was performed 11/2017.The log file confirms that the error 42.0000 occurred during use.This was obviously triggering a service intervention but this cannot be put in context to the completely damaged state of the returned components.The given information has conflicting aspects and dräger is not able to draw a reliable conclusion in regard to the root cause of the event.In general, turbine speed fluctuations may occur due to various reasons and the design concept of the device includes appropriate measures to respond.

Event Description

Please refer to initial mfr.Report.

• Brand Name: SAVINA
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9178926
• MDR Text Key: 167573992
• Report Number: 9611500-2019-00319
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K003068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1