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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD); OXIMETER, TISSUE SATURATION
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MMJ SA DE CV (USD); OXIMETER, TISSUE SATURATION Back to Search Results
Model Number 5100C-PA
Medical Device Problem Code Low Readings (2460)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/02/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the device gave low rso2 value of 15.They changed the cannula to larger size and used inotropes to managed blood pressure.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
NA
Common Device Name
OXIMETER, TISSUE SATURATION
Manufacturer (Section D)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX  32590
MDR Report Key8940300
Report Number2936999-2019-00578
Device Sequence Number2520738
Product Code MUD
UDI-Device Identifier10884521145573
UDI-Public10884521145573
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K082327
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number5100C-PA
Device Catalogue Number5100C-PA
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/06/2019
Supplement Date Received by Manufacturer10/09/2019
Initial Report FDA Received Date08/28/2019
Supplement Report FDA Received Date10/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age57 YR
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