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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JABIL CIRCUIT(SHANGHAI) LTD INVOS; OXIMETER, TISSUE SATURATION

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JABIL CIRCUIT(SHANGHAI) LTD INVOS; OXIMETER, TISSUE SATURATION Back to Search Results
Model Number DS5100C-PA
Device Problem Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the unit had low baselines.There was no patient harm associated with this event.
 
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Brand Name
INVOS
Type of Device
OXIMETER, TISSUE SATURATION
Manufacturer (Section D)
JABIL CIRCUIT(SHANGHAI) LTD
no 600 tian lin rd
shanghai 20023
CN  20023
Manufacturer (Section G)
JABIL CIRCUIT(SHANGHAI) LTD
no 600 tian lin rd
shanghai 20023
CN   20023
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key9293697
MDR Text Key165547886
Report Number2936999-2019-00926
Device Sequence Number1
Product Code MUD
UDI-Device Identifier10884521185890
UDI-Public10884521185890
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDS5100C-PA
Device Catalogue NumberDS5100C-PA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2019
Initial Date FDA Received11/07/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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