FDA Adverse Event Other Summary report: N

OPTIFLEX III CPM

MDR report key: 1743176 · Received June 28, 2010

Report

Report Number: 1022819-2010-00009
Event Type: Other
Date Received: June 28, 2010
Date of Event: March 23, 2010
Report Date: June 28, 2010
Manufacturer: CHATTANOOGA GROUP
Product Code: BXB
PMA / PMN Number: K841674
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UNIT FAILED INITIAL ELECTRICAL SAFETY TESTING. THE IEC CONNECTOR WAS PULLED OUT OF ITS RECEPTACLE WITH BURN MARKS ON IT. ONE PIN WAS MELTED OFF MAKING THE CONNECTOR UNUSABLE. A LOOSE CONNECTION WAS FOUND THAT COULD HAVE BEEN A CONTRIBUTING FACTOR. THE UNITS GROUNDING TESTED GOOD WITH ONLY .5 OHMS FROM FRAME TO PIN AND .8 OHMS RESISTANCE TO THE END OF THE PLUG. REPLACED THE IEC CONNECTOR BEFORE CONTINUING TO TEST THE UNIT AND THE UNIT PASSED WONDERFULLY. CONCLUSION: THE UNIT'S IEC CONNECTOR FAILED TO REMAIN INTACT, AND A CONNECTION WAS LOOSE WHICH IS THE CAUSE OF THE FIRE. I BELIEVE THE CONNECTION PULLED LOOSE AND MADE DIRECT CONTACT WITH THE FRAME OF THE UNIT.

Description of Event or Problem · 1

CUSTOMER ((B) (6) MEDICAL CENTER) COMPLAINED THAT POWER CORD PLUG-IN ON UNIT, PULLED OUT OF UNIT AND CAUGHT ON FIRE. THE UNIT WAS NOT IN USE AT THE TIME OF DISCOVERY. NO INJURY OCCURRED AND NO PATIENT WAS INVOLVED. THE PERSON WHO PULLED OUT THE CORD WAS ALSO NOT HARMED. DEVICE HAS MALFUNCTIONED AND THE DEVICE OR A SIMILAR DEVICE MARKETED BY THE MANUFACTURER WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OPTIFLEX III CPM		BXB	CHATTANOOGA GROUP	2090

Patients

Seq	Age	Sex	Outcome	Treatment
1