MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
Received Sep 28, 2017 · Event occurred Aug 7, 2017
Report 2021710-2017-06716 · MDR key 6902670
Device
Product problems
- Melted
- Melted
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
VYAIRE COMPLAINT #: (B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE FSR POWERED ON THE DEVICE AND THE ANALYZER BEGAN SMOKING. THE CHIP U10 WAS FOUND BURNING UP. HE REPLACED THE ANALYZER AND TESTED. ALL TO FACTORY SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A FOLLOW UP REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY ARE UNABLE TO PERFORM VOLUME, GAS OR BOX CALIBRATION. SHE ATTEMPTED TO LOCATE THE SOURCE OF THE ERROR AND FOUND THREE FUSES BLOWN AND DAMAGE TO THE INTERFACE BOARD. ONE OF THE IC CHIPS ON THE BOARD WAS VISIBLY MELTED. NO PATIENT INVOLVEMENT OR HARM.
Additional Manufacturer Narrative
AT THE TIME OF THE INITIAL SUBMISSION THE FAILURE INVESTIGATION REPORT WAS NOT INCLUDED. RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SYSTEM BOX HOWEVER NO INVESTIGATION COULD BE PERFORMED DUE TO THE PART BEING RETURNED IMPROPERLY PACKAGED, WITHOUT A COVER OR AN ELECTRO-STATIC DISCHARGE BAG, COMPROMISING THE FUNCTIONALITY OF THE PCBAS.