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

Catalog Number 8603800

Device Problems Device Emits Odor (1425); Failure to Deliver (2338); No Pressure (2994); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

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 the power supply unit fumed off by primus during operation.Switch off by the user.When the unit was switched on again, the message "power supply not connected" was displayed and the unit smelled burned.No patient injury reported.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

A dispatched service technician could trace the problem back to a malfunction of the power supply and replaced it.The device passed all consecutive tests and is back in use.An in-depth analysis of the replaced power supply was performed in reflection of the fact that it was in operation for 85986 hours.The log files were not available for analysis.The returned power supply unit was installed in a laboratory device.The battery of the primus had a remaining capacity of 95% at the time of power supply replacement.The smell of fire described by the user could be reproduced and is attributable to the heat conductive paste used in this ten years old power supply unit.An oily substance formed, which could lead to failures of some components.In the event of a power supply failure, the device continues to operate using the internal buffer batteries without limiting functionality.At the same time a power-supply error alarm is issued.The remaining capacity of the batteries is displayed to the user.In addition, a warning message is sent to the user if the battery capacity falls below the 20% and 10% limits.Manual ventilation with the built-in breathing bag remains possible.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9127437
• MDR Text Key: 186753301
• Report Number: 9611500-2019-00290
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• 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: 8603800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1