FDA Adverse Event Death Summary report: N

PRIMUS

MDR report key: 4950065 · Received July 23, 2015

Report

Report Number: 9611500-2015-00143
Event Type: Death
Date Received: July 23, 2015
Report Date: September 11, 2015
Manufacturer: DRÄGERWERK AG & CO. KGAA
Product Code: CBK
PMA / PMN Number: K042607
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION WAS STARTED BUT HAS NOT YET BEEN CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW UP-REPORT.

Additional Manufacturer Narrative · 1

AS DESPITE REQUEST THE PROSECUTOR HAS NOT PROVIDED FURTHER INFORMATION THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THE REPORTED INFORMATION DOES NOT INDICATE A FAILURE OF THE PRIMUS OR ONE OF ITS COMPONENTS. IN GENERAL, ANY COMPONENT FAILURE WILL RESULT IN CORRESPONDING ALARMS (E.G. VENTILATOR FAIL OR GAS MIXER FAIL). THE SAFETY CONCEPT OF THE DEVICE ENSURES THAT IN SUCH A CASE AT MANUAL VENTILATION WILL STILL BE POSSIBLE EVEN IF THE PRIMUS COMPLETELY SHUT DOWN. THE USER MAY THEN CONTINUE THE CASE BY ADJUSTING AN ADEQUATE O2 FLOW AND ¿ PRESUMED A FUNCTIONAL VAPORIZER IS CONNECTED - AGENT CONCENTRATION. IN CASE RELEVANT INFORMATION WILL BECOME AVAILABLE IN THE FUTURE WE WILL RESUME THE INVESTIGATION.

Description of Event or Problem · 1

PLEASE SEE INITIAL REPORT.

Description of Event or Problem · 1

ON (B)(6) 2015 DRAGER (B)(4) RECEIVED A LETTER FROM THE PROSECUTORS OFFICE IN (B)(6) REGARDING A MEDICAL INCIDENT WHICH OCCURRED AT THE (B)(6). THE PROSECUTOR INFORMED US ABOUT AN ON-GOING INVESTIGATION IN CONNECTION TO A PT WHO DIED DURING SURGERY WHILE BEING ANESTHETIZED BY PRIMUS APPARATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
480238	PRIMUS	ANESTHESIA UNITS	CBK	DRÄGERWERK AG & CO. KGAA	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death