R.O. WATER TREATMENT

MDR report key: 1964302 · Received January 19, 2011

Report

Report Number: 1423500-2011-00785
Event Type: Malfunction
Date Received: January 19, 2011
Date of Event: December 27, 2010
Report Date: December 27, 2010
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FIP
PMA / PMN Number: K822385
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4)

Additional Manufacturer Narrative · 1

(B)(4). THE PRODUCT SAMPLE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE ACTUAL RO DEVICE WAS EVALUATED AND THE REPORTED CONDITION: OF A BURNING SMELL WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE THE MOTOR. THE MOTOR AND PUMP HEAD WERE REPLACED. THE DEVICE WAS TESTED AS PER BAXTER OPERATING PROCEDURES AND PROTOCOLS AND PASSED ALL TESTING. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER (B)(4) TO REPORT THAT THE DEVICE HAD A BURNING SMELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	R.O. WATER TREATMENT	SUBSYSTEM, WATER PURIFICATION	FIP	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1