VAC-PAC 51631

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-09 for VAC-PAC 51631 manufactured by Natus Medical Incorporated.

Event Text Entries

[99885882] The customer was provided information for storage, repair, testing and replacement, and the customer opted to replace their vac-pac. 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.
Patient Sequence No: 1, Text Type: N, H10


[99885883] The customer contacted natus medical to report that their vac-pac patient positioning support device had a slow leak at the valve. There was no report of death, injury or delay in treatment, and no patient involvement was reported. The vac-pac device has been reported to have been purchased in (b)(6) 2016 and has been destroyed at the user facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3018859-2018-00100
MDR Report Key7261350
Report SourceUSER FACILITY
Date Received2018-02-09
Date of Report2018-01-11
Date Mfgr Received2018-01-11
Date Added to Maude2018-02-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKYLE HORTON
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal98108
Manufacturer Phone2068343921
Manufacturer G1NATUS MEDICAL INCORPORATED
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal Code98108
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVAC-PAC
Generic NameVAC-PAC
Product CodeCCX
Date Received2018-02-09
Model Number51631
Lot NumberN050416-06
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORATED
Manufacturer Address5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-02-09

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