DEVILBISS
Received Feb 2, 2018 · Event occurred Jun 8, 2016
Report 2515872-2018-00003 · MDR key 7237591
Device
Product problems
- Arcing
- Arcing
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE INCIDENT WAS REPORTED TO DEVILBISS HEALTHCARE'S (B)(4) DISTRIBUTOR OF THE DEVICE WHO STATED THERE WAS "DAMAGE TO THE CONNECTION OF THE (J8) AC VOLTAGE POWER CONNECTOR TO PRINTED CIRCUIT BOARD (PCB)". THE (B)(4) DISTRIBUTOR NOTED THAT THE (J8) AC VOLTAGE POWER CONNECTOR WAS ARCING AND THAT IT WAS COLD SOLDERED TO THE PRINTED CIRCUIT BOARD (PCB) BOARD. THE (B)(4) DISTRIBUTOR REPORTED THERE APPEARED TO BE DAMAGE TO THE SOLDER JOINT AND THE DAMAGE WAS MORE THAN LIKELY CAUSED BY EXCESSIVE FORCE OR MECHANICAL STRESS APPLIED TO THE CONNECTOR. THE UNIT WAS RETURNED TO DEVILBISS HEALTHCARE AND AN ENGINEERING INSPECTION AND EVALUATION WAS PERFORMED, WHICH CONFIRMED THAT THE CPAP UNIT HAD A COLD SOLDER JOINT BETWEEN THE PRINTED CIRCUIT BOARD (PCB) AND THE (J8) AC VOLTAGE POWER CONNECTOR. THE COLD SOLDER JOINT WAS THE RESULT OF IMPROPER WELDING TECHNIQUE DURING THE ELECTRONIC ASSEMBLY PROCESS OF THE PRINTED CIRCUIT BOARD (PCB). THIS IS LOCALIZED TO THE POSITION ON THE BOARD AND INTERNAL TO THE DEVICE. DEVILBISS HEALTHCARE HAS NOTIFIED THE PRINTED CIRCUIT BOARD (PCB) MANUFACTURER.
Description of Event or Problem
THE DEVILBISS HEALTHCARE'S (B)(4) DISTRIBUTOR REPORTED THE CPAP DV51UK,'S (J8) AC VOLTAGE POWER CONNECTOR SOLDERED TO THE INTERNAL PRINTED CIRCUIT BOARD (PCB) WAS ARCING. THE (B)(4) DISTRIBUTOR REPORTED THERE WAS NO PATIENT HARM.