FDA.reportPublic FDA data

MAUDE MDR 7427114

MDR report key
7427114
Report number
3018859-2018-00113
Event key
0
Event type
3
Date of event
2018-03-15
Date received
2018-04-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JIM FITZGERALD
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
1VAC-PACVAC-PACNATUS MEDICAL INCORPORATEDCCX51631N020617-05Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-1201. O

Event Narratives#

N

Patient 1

THE SUSPECT VAC PAC DEVICE WAS RETURNED TO NATUS AND EVALUATED. A VISUAL INSPECTION CONFIRMED THAT THE SIDE BAFFLE ON FRONT OF VAC-PAC HAS 0.7 CM HOLE THAT IS THREE INCHES FROM THE SEAM. THE LIKELY CAUSE OF THE LOSS OF SUCTION IS CUSTOMER-CAUSED DAMAGE. THE CUSTOMER WAS PROVIDED INFORMATION FOR STORAGE, REPAIR, TESTING AND REPLACEMENT. USERS ARE INSTRUCTED TO CHECK THE VAC PAC DEVICE BEFORE AND AFTER EACH USE AND NOT TO USE THE DEVICE IF THERE IS KNOWN DAMAGE OR A LEAK. USERS ARE ALSO INSTRUCTED TO REPLACE UNITS OLDER THAN TWO YEARS THAT ARE USED SEVERAL TIMES A WEEK.

D

Patient 1

THE CUSTOMER REPORTED THAT THIS VAC-PAC LOST SUCTION DURING SURGERY. THE VAC-PAC SOFTENED DURING SURGERY, AND THE STAFF CONNECTED IT TO CONTINUOUS SUCTION AND COMPLETED THE SURGICAL PROCEDURE. THERE HAS BEEN NO REPORT OF DEATH, SERIOUS INJURY OR DELAY IN PATIENT TREATMENT. THE VAC-PAC HAS BEEN RETURNED TO NATUS MEDICAL FOR QA EVALUATION ON 4/10/2018. THE VAC-PAC WAS PURCHASED IN (B)(6) 2017.