FDA.reportPublic FDA data

MAUDE MDR 7794970

MDR report key
7794970
Report number
3018859-2018-00145
Event key
0
Event type
3
Date received
2018-08-17
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
JAMES 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 INCORPORATEDCCX51630301724-509EN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-1701. O

Event Narratives#

N

Patient 1

THE CUSTOMER WAS PROVIDED INFORMATION FOR STORAGE, REPAIR, TESTING AND REPLACEMENT. NATUS TECHNICAL SERVICE ADVISED THE USER THAT THE VAC-PAC IFU NOTES TO CHOOSE A VAC-PAC THAT SUPPORTS THE PATIENT AND TO USE ADDITIONAL SUPPORTS AS NEEDED. 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.

D

Patient 1

IT WAS REPORTED TO NATUS THAT A VAC-PAC LOST SUCTION DURING A SURGICAL PROCEDURE WHILE CONNECTED TO CONTINUOUS SUCTION. UPON LOSS OF SUCTION, THE PATIENT BEGAN SLIDING OFF OF THE OPERATING ROOM TABLE. THE ANESTHESIOLOGIST WAS ABLE TO STOP THE PATIENT'S SLIDE. THERE WAS NO HARM CAUSED TO THE PATIENT. IT WAS NOT REPORTED WHETHER THERE WAS ANY VISIBLE DAMAGE TO THE VAC-PAC. THE VAC-PAC WAS REPORTED TO HAVE BEEN PURCHASED OVER TWO YEARS PRIOR TO THE DATE OF THE EVENT.