FDA Adverse Event Malfunction Summary report: N

840 VENTILATOR

MDR report key: 3830049 · Received March 11, 2014

Report

Report Number: 8020893-2014-00578
Event Type: Malfunction
Date Received: March 11, 2014
Date of Event: February 1, 2014
Report Date: February 10, 2014
Manufacturer: COVIDIEN, NELLCOR
Product Code: CBK
PMA / PMN Number: K970460
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NO INFORMATION

Narratives

Additional Manufacturer Narrative · 1

A COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) TO BREATHE DELIVERY (BD) CABLE ASSAY AS A PRECAUTION. IN ADDITION, THE CSE UPDATED THE DEVICE'S SOFTWARE TO REV. AK. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST, EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TESTING (PVT) ACCORDING TO MANUFACTURER SPECIFICATIONS. A SERVICE HISTORY REVIEW HAS BEEN PERFORMED FOR THE ABOVE LISTED SERIAL NUMBER BY THE MANUFACTURER. NO SIMILAR EVENTS WERE FOUND IN THE SERVICE HISTORY RECORD. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

Description of Event or Problem · 1

A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR'S "SCREEN DISPLAY NOT WORKING". IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT TIME OF EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
145644	840 VENTILATOR	CBK	CBK	COVIDIEN, NELLCOR	840

Patients

Seq	Age	Sex	Outcome	Treatment
1