FDA Adverse Event Death Summary report: N

MAXTEC MAXVENTURI MEDICAL OXYGEN SENSOR AND MAXTEC MAXVENTURI

MDR report key: 1813619 · Received August 19, 2010

Report

Report Number: 9611451-2010-00493
Event Type: Death
Date Received: August 19, 2010
Report Date: August 5, 2010
Manufacturer: MAXTEC INC
Product Code: CCL
Adverse Event: Yes
Product Problem: Yes
Report Source: Distributor report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE (B)(4) MAXTEC MAXVENTURI MEDICAL OXYGEN SENSOR AND THE MAXTEC MAXVENTURI ASSOCIATED WITH THIS REPORTED INCIDENT WERE MFG BY (B)(4) AND ARE BEING DISTRIBUTED BY (B)(4). THESE PRODUCTS ARE NOT DISTRIBUTED BY FPH IN THE USA. HOWEVER, THESE PRODUCTS ARE BEING PROMOTED BY FPH'S SALES TEAM IN THE USA. FPH HAS ADVISED (B)(4) OF THIS REPORTED INCIDENT. WE ARE WORKING TO PROVIDE ANY SUPPORT REQUIRED FOR THEIR INVESTIGATION. (B)(4) WILL PROVIDE THEIR INVESTIGATION RESULTS DIRECTLY TO FDA. FPH HAS NOT RECEIVED COMPLAINTS OF ANY SIMILAR INCIDENTS FOR THESE PARTICULAR PRODUCTS.

Description of Event or Problem · 1

A HOSP IN (B)(6) REPORTED THE FOLLOWING TO A FISHER AND PAYKEL HEALTHCARE (FPH) REP IN (B)(4) INVOLVING AN (B)(4) MAXTEC MAXVENTURI MEDICAL OXYGEN SENSOR AND A MAXTEC MAXVENTURI: "(B)(6) FROM (B)(6) REPORTED THAT OXYGEN READING IS JUMPING TO 100%. (B)(6) FROM (B)(6) INFORMED ME THAT THE PT'S SATS DROPPED AS A RESULT OF THE MAX VENTURI GOING FROM 100% OXYGEN TO 21%. THE MEDICAL STAFF DID EVERYTHING THEY COULD TO BRING THE OXYGEN CONCENTRATION BACK UP BUT THIS FAILED AND THE PT SUFFERED AS A RESULT." ON (B)(6) 2010, THE HOSP NOTIFIED THE FPH REP IN (B)(4) THAT THE PT DIED. THE CAUSE OF DEATH IS UNK AT THIS STAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAXTEC MAXVENTURI MEDICAL OXYGEN SENSOR AND MAXTEC MAXVENTURI	UNK	CCL	MAXTEC INC	R211P03-004

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death