FDA.reportPublic FDA data

MAUDE MDR 7077516

MDR report key
7077516
Report number
3018859-2017-00988
Event key
0
Event type
3
Date received
2017-12-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JEFFREY MANTKOWSKI
Address
5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US
Phone
206-206-2062
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WARM SCALE 23WARM SCALE 23NATUS MEDICAL INC.FRW56328Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-0101. O

Event Narratives#

N

Patient 1

THE DEVICE WAS RETURNED TO NATUS FOR FACTORY SERVICE INSPECTION/REPAIR. THE SERVICE TESTING DID NOT SHOW ANY ISSUES OTHER THAN AN OLDER BATTERY THAT WAS REPLACED TO ALLOW FOR FURTHER TESTING. THERE IS NO INDICATION THAT THE BATTERY FAILED EARLY OR PREMATURELY. THE DEVICE PASSED ALL QUALITY ASSURANCE TESTING AND HAS BEEN RETURNED TO THE CUSTOMER PER NORMAL REPAIR PROCEDURE.

D

Patient 1

A CUSTOMER'S BIOMED CONTACTED NATUS TECHNICAL SERVICE FOR THE PART NUMBER AND PRICING OF THE INFANT TRAY AND SHELF FOR THE WARM SCALE. WHEN ASKED WHY REPLACEMENTS WERE REQUIRED, THE CUSTOMER REPORTED THAT THE TRAY AND THE INSERT HAD MELTED AREAS. THE CUSTOMER WENT FURTHER TO STATE THAT DEVICE WAS NOT IN USE WITH A PATIENT WHEN THE ISSUE WAS DISCOVERED AND THERE WERE NO ENVIRONMENTAL SAFETY CONCERNS. THE CUSTOMER STATED THAT THE CLINICAL STAFF HAD BEEN USING THE DEVICE TO WARM UP A STACK OF CLOTHS FOR PATIENTS. NO DEATH, HARM OR DELAY IN PATIENT PROCEDURES HAVE BEEN REPORTED.