PUSH TO SET INTERMITTENT SUCTION REGULATOR 1251 8705-1251-907

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 REGULATOR 1251 8705-1251-907 manufactured by Ohio Medical.

Event Text Entries

[48932592]
Patient Sequence No: 1, Text Type: N, H10


[48932593] A user facility reported to us that the device had "no suction on int, no cycle" on (b)(6) 2014. There was no patient involvement, and the incident did not result in a delay of treatment. The device was evaluated on 07/31/2014 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


[49179951] Clinical assessment of the failure mode "vacuum regulator fails to provide suction" 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


[49179952] Clinical assessment of the failure mode "vacuum regulator fails to provide suction" 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 Number1419185-2016-00011
MDR Report Key5690290
Date Received2016-05-31
Date of Report2016-05-31
Date of Event2014-07-31
Date Mfgr Received2014-07-18
Device Manufacturer Date2008-11-06
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 Phone8478556318
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 REGULATOR
Generic NamePTS ISU
Product CodeKDP
Date Received2016-05-31
Returned To Mfg2014-07-24
Model Number1251
Catalog Number8705-1251-907
Lot NumberISU087158
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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