FDA Adverse Event Malfunction Summary report: N

ROHS MICROSENSOR BASIC KIT

MDR report key: 6122627 · Received November 22, 2016

Report

Report Number: 1226348-2016-10800
Event Type: Malfunction
Date Received: November 22, 2016
Manufacturer: CODMAN & SHURTLEFF, INC.
Product Code: GWM
PMA / PMN Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. IT WAS FOUND THAT THE CATHETER MATERIAL WAS KINKED 3.1 CM FROM THE TIP OF THE CATHETER. THE CATHETER MATERIAL WAS SEVERELY MASHED 60 CM, 74.1 CM AND 92.5 CM FROM THE TIP OF THE CATHETER. SUTURE MATERIAL WAS ATTACHED TO THE CATHETER MATERIAL. THE DEVICE PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TEST. THE SUPPLIER WAS UNABLE TO CONFIRM THE REPORTED. ISSUE. THE DEVICE FUNCTIONED AS INTENDED. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Additional Manufacturer Narrative · 1

THE 510(K) # OF SIMILAR PRODUCT CODE OF 826631: K914479. (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

Description of Event or Problem · 1

THE SENSORS SHOWED WRONG VALUES AND CAN'T ZEROED NOR ACTIVATED. ALSO IN THE EXPLANTED SITUATION, THEY SHOWED HIGH VALUES. IN THE LAST TIME THIS HAPPENED SEVERAL TIMES WITH DIFFERENT SENSORS (SINCE THE ROHS SENSOR) ON SEVERAL MONITORS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
773337	ROHS MICROSENSOR BASIC KIT	DEVICE, INTRACRANIAL PRESSURE MONITORING	GWM	CODMAN & SHURTLEFF, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1