PUSH TO SET INTERMITTENT SUCTION UNIT 1251 8701-1251-908

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-31 for PUSH TO SET INTERMITTENT SUCTION UNIT 1251 8701-1251-908 manufactured by Ohio Medical.

Event Text Entries

[48511657]
Patient Sequence No: 1, Text Type: N, H10


[48511658] A user facility reported to us that the "units are not working" on 2/27/2015. There was no patient involvement, and the incident did not result in a delay of treatment. The device was evaluated on 04/21/2015 and it was noted that the device had a damaged diaphragm. Our risk document classifies the severity of a damaged diaphragm as "potentially requiring medical intervention to prevent permanent impairment of a body function or permanent damage to a body structure". We are obtaining further clinical evaluation of the risk of this failure and will provide follow up to this report once obtained.
Patient Sequence No: 1, Text Type: D, B5


[49179493] Clinical assessment of the failure mode "damaged diaphragm" has been obtained and it has been determined that this occurrence does not represent a reportable malfunction due to no evidence existing to reasonably suggest that the malfunction would be likely to cause or contribute to death or serious injury if it were to recur. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[49179494] Clinical assessment of the failure mode "damaged diaphragm" has been obtained and it has been determined that this occurrence does not represent a reportable malfunction due to no evidence existing to reasonably suggest that the malfunction would be likely to cause or contribute to death or serious injury if it were to recur.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1419185-2016-00004
MDR Report Key5690268
Date Received2016-05-31
Date of Report2016-05-31
Date of Event2015-04-21
Date Mfgr Received2015-02-27
Device Manufacturer Date2008-03-18
Date Added to Maude2016-05-31
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 Phone8478856318
Manufacturer G1OHIO MEDICAL
Manufacturer Street1111 LAKESIDE DR
Manufacturer CityGURNEE IL 60031
Manufacturer CountryUS
Manufacturer Postal Code60031
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePUSH TO SET INTERMITTENT SUCTION UNIT
Generic NamePTS ISI
Product CodeKDP
Date Received2016-05-31
Returned To Mfg2015-03-05
Model Number1251
Catalog Number8701-1251-908
Lot NumberISU087045
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOHIO MEDICAL
Manufacturer Address1111 LAKESIDE DR GURNEE IL 60031 US 60031


Patients

Patient NumberTreatmentOutcomeDate
10 2016-05-31

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