FDA Adverse Event Malfunction Summary report: N

NEWPORT MEDICAL INSTRUMENTS, INC.

MDR report key: 6521699 · Received April 26, 2017

Report

Report Number: 2023050-2017-05220
Event Type: Malfunction
Date Received: April 26, 2017
Report Date: May 25, 2017
Manufacturer: COSTA MESA MFG DC
Product Code: CBK
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ANALYSIS #(B)(4):VERIFIED CUSTOMER COMPLAINT THAT COMPRESSOR WAS LOUD. TOP COVER WAS REMOVED TO CHECK FOR INTERNAL ISSUES PRIOR TO POWERING ON THE COMPRESSOR. IT WAS OBSERVED THAT ONE SIDE OF BOTH HANDLES WERE SLIGHTLY LOOSE AND THE NOISE SUPPRESSION FOAM HAD BEEN REMOVED FROM THE TOP COVER. NO DAMAGE WAS OBSERVED ON THE PUMP. AC POWER WAS CONNECTED AND UNIT WAS POWERED ON AND STARTED RUNNING. A SLIGHT RA TTLING NOISE WAS OBSERVED. FURTHER INSPECTION FOUND THE BOTTOM OF THE UNIT WAS BENT AT THE CORNER, AND THE PUMP MOUNTING PLATE WAS BENT ON ONE SIDE WITH A MOUNTING SCREW NOT SECURED.

Additional Manufacturer Narrative · 1

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE COMPRESSOR WAS LOUD AND RATTLES. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. DEVICE INFORMATION WAS NOT PROVIDED. THE COMPRESSOR TO BE RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE COMPRESSOR WAS LOUD AND RATTLES. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. DEVICE INFORMATION WAS NOT PROVIDED. THE COMPRESSOR TO BE RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
303539	NEWPORT MEDICAL INSTRUMENTS, INC.	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	COSTA MESA MFG DC

Patients

Seq	Age	Sex	Outcome	Treatment
1