FDA Adverse Event Malfunction Summary report: N

PUREPOINT

MDR report key: 1791469 · Received August 6, 2010

Report

Report Number: 2028159-2010-01380
Event Type: Malfunction
Date Received: August 6, 2010
Date of Event: July 8, 2010
Report Date: July 8, 2010
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQF
PMA / PMN Number: K062624
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE SYSTEM MESSAGE IN THE EVENT LOG. THE CABLES WERE RESEATED AND THEN REPLACED. THE SOFTWARE WAS RELOADED. THE COMPANY SERVICE REP RECOMMENDED THE SYSTEM BE RETURNED FOR IN-HOUSE EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD¿L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

Description of Event or Problem · 1

ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE CUSTOMER REPORTED A SYSTEM MESSAGE DISPLAYED. THE SYSTEM WOULD NOT ADVANCE TO THE READY MODE. ADD¿L INFO STATED THE SYSTEM WAS TURNED ON FIRST THING IN THE MORNING AND ALL THE SETTINGS WERE DISPLAYED. THE PT WAS BROUGHT INTO THE ROOM AND IT WAS NOTICED THAT NO SETTINGS WERE DISPLAYING. A SYSTEM MESSAGE DISPLAYED. THE SYSTEM WAS REBOOTED A COUPLE TO TIMES BUT THE SYSTEM MESSAGE WOULD NOT CLEAR. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED AS PLANNED. NO PT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PUREPOINT	LASER, OPHTHALMIC	HQF	ALCON - IRVINE TECHNOLOGY CENTER	PUREPOINT	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK