FDA Adverse Event Malfunction Summary report: N

RADICAL-7

MDR report key: 4913327 · Received July 9, 2015

Report

Report Number: 2031172-2015-00880
Event Type: Malfunction
Date Received: July 9, 2015
Date of Event: June 9, 2015
Report Date: June 9, 2015
Manufacturer: MASIMO CORPORATION
Product Code: DQA
PMA / PMN Number: K140188
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE RETURNED DEVICE WAS EVALUATED. DURING TESTING IT WAS FOUND THAT THE RADICAL-7 DISPLAY SHUTS DOWN WITHIN A FEW SECONDS (SCREEN BLANK) AND 10 BEEPS ARE HEARD. THE 10 BEEPS ALARM LOOPED CONTINUOUSLY UNTIL THE DEVICE WAS SHUT DOWN BY HOLDING THE POWER KEY FOR A FEW SECONDS OR UNTIL THE DEVICE BATTERY CHARGE RAN OUT. IN THIS CONDITION, THE DEVICE WAS UNABLE TO OPERATE FOR MORE THAN A FEW SECONDS. THE INSTRUMENT BOARD WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED. A REVIEW OF THE HISTORY FOR THIS DEVICE WAS PERFORMED AND IT WAS CONCLUDED THAT THE DEVICE WAS IN THE FIELD FOR OVER TWO (2) YEARS WITH NO PREVIOUS RETURNS FOR SERVICING OR OTHER ISSUES PRIOR TO THE REPORTED EVENT. THE 510(K) NUMBER IS K140188. THE DEVICE MANUFACTURE DATE IS 01/2/2013.

Additional Manufacturer Narrative · 1

ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE TURNS OFF SPORADICALLY WITH OR WITHOUT BEING CONNECTED TO THE AC. THERE WAS NO KNOWN PATIENT IMPACT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
444752	RADICAL-7	OXIMETER	DQA	MASIMO CORPORATION	23786

Patients

Seq	Age	Sex	Outcome	Treatment
1