FDA Adverse Event Malfunction Summary report: N

ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT

MDR report key: 6181995 · Received December 16, 2016

Report

Report Number: 1226348-2016-10860
Event Type: Malfunction
Date Received: December 16, 2016
Date of Event: November 24, 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: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE 510(K) # OF SIMILAR PRODUCT CODE OF 826638: K974088. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS WAS PERFORMED AND FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THAT THERE WAS NO VISIBLE DAMAGE TO THE SENSOR, CATHETER MATERIAL OR CONNECTOR. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. THE DEVICE FUNCTIONED AS INTENDED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem · 1

DAMAGED DEVICE DURING PLACEMENT OF A PIC, THE NUT HAS TWISTED. USE OF ANOTHER DEVICE. NO PATIENT CONSEQUENCE. THE PROCEDURE WAS LENGTHENED OF MORE THAN 30 MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
833271	ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT	DEVICE, INTRACRANIAL PRESSURE MONITORING	GWM	CODMAN & SHURTLEFF, INC.		CVFCL1

Patients

Seq	Age	Sex	Outcome	Treatment
1