CARE-E-VAC 3 758000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for CARE-E-VAC 3 758000 manufactured by Ohio Medical Llc.

Event Text Entries

[117017635] Field correction 1419185-7/24/18-001-c has been initiated for correction of other potentially affected devices.
Patient Sequence No: 1, Text Type: N, H10


[117017636] On 01/29/2018 a complaint was received for the care-e-vac 3 device in which the customer stated "unusable condition". The device was returned on 2/7/2018. Device was retained by engineering and a replacement device was sent to the customer. On (b)(6) 2018 there was an occurence in house during assembly of the care-e-vac 3 device in which same time of effect occured (melted wires leading from battery to the pc board). Ship hold was initiated immediately and investigation began looking further into the cause of the burning/ melted wires. This device was re-evaluated by engineering with comparison to failure which occured in house. Same effects of failure were observed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1419185-2018-00003
MDR Report Key7770873
Date Received2018-08-09
Date of Report2018-08-09
Date Mfgr Received2018-06-22
Device Manufacturer Date2018-01-22
Date Added to Maude2018-08-09
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 ContactMS. JESSICA BARRILE
Manufacturer Street1111 LAKESIDE DR
Manufacturer CityGURNEE IL 60031
Manufacturer CountryUS
Manufacturer Postal60031
Manufacturer Phone8478556318
Manufacturer G1OHIO MEDICAL LLC
Manufacturer Street1111 LAKESIDE DR
Manufacturer CityGURNEE IL 60031
Manufacturer CountryUS
Manufacturer Postal Code60031
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCARE-E-VAC 3
Generic NamePORTABLE SUCTION DEVICE
Product CodeBTA
Date Received2018-08-09
Returned To Mfg2018-02-07
Model Number758000
Catalog Number758000
Lot NumberCEB181002
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOHIO MEDICAL LLC
Manufacturer Address1111 LAKESIDE DR GURNEE IL 60031 US 60031


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-09

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