FDA Adverse Event Malfunction Summary report: N

AUTOCAT2 WAVE

MDR report key: 1022880 · Received March 28, 2008

Report

Report Number: 1219856-2008-00153
Event Type: Malfunction
Date Received: March 28, 2008
Date of Event: October 17, 2007
Report Date: March 28, 2008
Manufacturer: ARROW INTL., INC.
Product Code: DSP
PMA / PMN Number: K060309
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

AFTER EVALUATION, IT WAS DETERMINED THAT THE EVENT WAS MDR REPORTABLE. EVALUATION: THE POWER SUPPLY & BATTERY WERE RETURNED. THE RECEIVED BATTERY WAS TESTED PER PROCEDURE AND PASSED ALL TESTS. THE POWER SUPPLY FAILED TO POWER ON WHILE CONNECTED TO AC POWER. A DEVICE HISTORY RECORD RE-REVIEW WAS CONDUCTED ON THE REPORTED INTRA-AORTIC BALLOON PUMP SERIAL NUMBER & IT MET ALL SPECIFICATIONS & PASSED ALL IN-PROCESS TESTING. CONCLUSION: THE CAUSE OF THE REPORTED DEFECT IS A FAILED POWER SUPPLY. IT IS NOT POSSIBLE TO DETERMINE HOW THE SUPPLY WAS COMPROMISED.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE ON A PT, THE PUMP EXPERIENCED SYSTEM BATTERY ALARM AND BATTERY RUN TIME LESS THEN 20 MINUTES. AS A RESULT, THE PUMP WAS SWITCHED OUT. THERE WERE NO REPORTED PT COMPLICATIONS. THE FIELD SERVICE REP WAS PHONED TO CHECK THE PUMP. FIELD SERVICE REPORT STATES THE FOLLOWING: "PUMP WAS NOT POWERED UP. FOUND POWER SUPPLY NOT CHARGING BATTERY. BATTERY VOLT - 11.7. REPLACED POWER SUPPLY AND BATTERY. CHARGE VOLTAGE - 13.5V. OK INSTALL FCN 13, INSTALL FCN 14 2.23 SOFTWARE. ENLARGE VENT HOLE IN WATER BOTTLE PER ELECTRICAL SAFETY." THE PUMP WAS DEEMED OPERATIONAL AND RETURNED TO SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOCAT2 WAVE	INTRA-AORTIC BALLOON PUMP PRODUCTS	DSP	ARROW INTL., INC.		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK