MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
Received Sep 28, 2017 · Event occurred Jul 17, 2017
Report 2021710-2017-06718 · MDR key 6902880
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE FSR DETERMINED THAT THE BOX CALIBRATION COULD NOT BE PERFORMED. CONSTANT 'CLOSE DOOR' ERROR MESSAGE APPEARS AND A BURNING SMELL WAS NOTICED. HE LOCALIZED THE ISSUE TO THE INTERFACE CARD WHERE AN IC CHIP ON THE CARD BEGAN TO MELT. A REPLACEMENT CARD WAS INSTALLED AND THE DEVICE MEETS ALL FACTORY SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A FOLLOW UP REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED THE IMPULSE OSCILLOMETER (IOS) THAT IS CONNECTED TO THE SYSTEM IS GETTING GENERAL INITIALIZATION FAILED, IOS NOT FOUND. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT OR HARM ASSOCIATED WITH THE EVENT.
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.