FDA Adverse Event Malfunction Summary report: N

4D DC SENSOR MEDIUM

MDR report key: 3925170 · Received June 20, 2014

Report

Report Number: 2031172-2014-00092
Event Type: Malfunction
Date Received: June 20, 2014
Date of Event: May 21, 2014
Report Date: May 21, 2014
Manufacturer: MASIMO CORPORATION
Product Code: DQA
PMA / PMN Number: K111403
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

EIGHT (8) ATTEMPTS HAVE BEEN MADE IN ORDER TO OBTAIN THE PRODUCT FOR EVALUATION. ON (B)(6) 2014, THE USER FACILITY INDICATED THAT THE DEVICE WILL BE RETURNED TO MASIMO FOR FURTHER EVALUATION. ONCE THE INVESTIGATION ON THE UNIT IS PERFORMED, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE CUSTOMER REQUESTED AN EVALUATION OF HER PRONTO-7 AND SENSORS. SHE INDICATED THAT THE DEVICE AND SENSOR ARE NOT PICKING UP READINGS AND/OR NOT GIVING ACCURATE READINGS. ACCORDING TO THE CUSTOMER, SHE TESTED THE PRODUCT ON HERSELF BY PLACING THE MEDIUM SENSOR ON OPPOSITE RING FINGERS WHICH ON THE LEFT HAND 15 AND RIGHT HAND 13. SHE INDICATED THAT THE RESULTS SHOWED INACCURATE OR NO READINGS ON EACH SENSOR. CUSTOMER WOULD LIKE DEVICE AND SENSORS CHECKED FOR ACCURACY. NO BLOOD GAS TEST SAMPLES ARE AVAILABLE. NO PATIENT INCIDENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
363425	4D DC SENSOR MEDIUM		DQA	MASIMO CORPORATION	SC-X

Patients

Seq	Age	Sex	Outcome	Treatment
1	30 YR