FDA Adverse Event Malfunction Summary report: N

AIA-900

MDR report key: 7355204 · Received March 20, 2018

Report

Report Number: 8031673-2018-02956
Event Type: Malfunction
Date Received: March 20, 2018
Date of Event: December 20, 2016
Report Date: March 20, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 20 DECEMBER 2016. THE FSE PERFORMED HAND TOUCH ADJUSTMENT AND LEVEL SENSE ADJUSTMENT. THE ENGINEER RAN CONTROLS AND VERIFIED PROPER LIQUID SENSE. THE AIA-900 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS THE ADJUSTMENTS TO HAND TOUCH AND LEVEL SENSE.

Description of Event or Problem · 0

ON (B)(6) 2016 A CUSTOMER REPORTED ERROR 3064 FLUID LEVEL SIGNAL MALFUNCTION AFTER SERVICE WITH THEIR AIA-900 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING IPTH PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OF REPORTING PATIENT RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
198737	AIA-900	AIA-900, PRODUCT CODE: KHO	KHO	TOSOH CORPORATION	AIA-900

Patients

Seq	Age	Sex	Outcome	Treatment
1