MASIMO SENSOR

Report

Report Number: 2031172-2014-00603
Event Type: Death
Date Received: December 31, 2014
Date of Event: November 25, 2014
Report Date: December 2, 2014
Manufacturer: MASIMO CORPORATION
Product Code: DQA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ATTEMPTS FOR THE RETURN OF THE SENSOR AS WELL AS ADDITIONAL INFO REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE SENSOR INVOLVED IN THE REPORTED EVENT. THE CUSTOMER INDICATED THAT THE SENSOR USED FOR THIS EVENT WAS DISCARDED AND THE SENSOR LOT INFO WAS NOT AVAILABLE. IF NEW INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT "PATIENT S/P CARDIAC ARREST ON HYPOTHERMIA. THE PT HAD A MASIMO SET IN USE. THE FINGER PROBE READING WAS 92% WITH A GOOD WAVE FORM. STAFF WAS HIGHLY DEPENDENT ON THIS 92% READING. ABG WAS DONE @ 0528 WHICH SHOWED PH: 7.25, PCO2 OF 40, PO2 43, HCO2 19, SAT ON ABG 82%. PTS FIO2 ON VENT HAD TO BE INCREASED FROM 50% TO 100% PTS PO2 107 AFTER INCREASING FIO2." ADDITIONAL INFO RECEIVED INDICATED THAT THE PT WAS A (B)(6) YEAR OLD MALE WHO WEIGHTED (B)(6). AN UNK MASIMO SENSOR AND CABLE WAS USED. (B)(4) WAS NOT ON SITE WHEN THE REPORTED EVENT OCCURRED, AND THE PRODUCT WAS NOT SAVED. A PHILIPS MONITOR WITH A MMS MODULE WAS USED. THE PT'S PRE-EXISTING CONDITIONS INCLUDED COPD AND HYPERTENSION. THE PT DID NOT HAVE A HISTORY OF HEART DISEASE. THE REPORTED INACCURATE READINGS OCCURRED ON (B)(6) 2014 AND THE PT PASSED AWAY IN THE ON (B)(6) 2014. MASIMO PRODUCT WAS IN USE ON THE PT WHEN HE PASSED AWAY, AND MEDICAL INTERVENTION INCLUDING DOUBLING THE FIO2 ON THE VENTILATOR FROM 50% TO 100%.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
863314	MASIMO SENSOR	OXIMETER	DQA	MASIMO CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Death