ISU, BSC, STD, CW DOM 8700-0000-801

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-10-09 for ISU, BSC, STD, CW DOM 8700-0000-801 manufactured by Ohio Medical Corporation.

Event Text Entries

[20660756] This malfunction was previously reported on (b)(6) 2014 (mfr report # 1419185-2014-00003), however, multiple devices were included on that report in error. The device is a vacuum regulator intended to regulate suction to remove body fluids. On (b)(6) 2014 it was noted that 14 devices which had been returned for repair contained diaphragms which had significant tears in them after device life of less than 6 months. At the time on quality assurance awareness on (b)(6) 2014, previous returns were reviewed further to determine if any other newer devices had been returned with confirmed damaged diaphragms. One additional device was noted. It has been determined that a tear in the regulator diaphragm while in use (after vacuum has been set) could result in an increase in vacuum to the patient than what had been originally set.
Patient Sequence No: 1, Text Type: D, B5


[20998401] Device is a vacuum regulator. The device achieves its function via a regulator module that is equipped with a diaphragm. The user filed a complaint that the regulator gauge was jumpy. During the investigation of the returned devices it was discovered that the malfunctioning units had their diaphragms torn. The user did not report any patient involvement nor any adverse event. The user also did not file a form fda-3500a. The manufacturer is filing form fda-3500a because this was a malfunction that if it were to recur, it would have the potential to cause some patient harm. Investigation into the root cause in ongoing as of the date of this report and it has not yet been determined the extent to which remedial action would be appropriate to prevent an unreasonable risk of substantial harm to public health. This malfunction was previously reported on (b)(4) 2014 (mfr report # 1419185-2014-00003), however, multiple devices were included on that report in error.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1419185-2014-00017
MDR Report Key4181762
Report Source99
Date Received2014-10-09
Date of Report2014-10-09
Date of Event2014-06-12
Device Manufacturer Date2014-01-01
Date Added to Maude2014-10-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street1111 LAKESIDE DR.
Manufacturer CityGURNEE IL 60031
Manufacturer CountryUS
Manufacturer Postal60031
Single Use0
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameISU, BSC, STD, CW DOM
Generic NameVACUUM REGULATOR
Product CodeKDP
Date Received2014-10-09
Returned To Mfg2014-06-18
Model Number8700-0000-801
Lot NumberISU137497
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOHIO MEDICAL CORPORATION
Manufacturer AddressGURNEE IL US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-09

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