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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-US
Device Problem Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/30/2019
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 intermittent low baselines.They were getting low baselines on healthy patients.There was no patient injury.
 
Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The device passed the all test criteria.The investigation found the device to function normally.No new formal investigation is required, the event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key9121203
MDR Text Key160307182
Report Number2936999-2019-00785
Device Sequence Number1
Product Code MUD
UDI-Device Identifier10884521185913
UDI-Public10884521185913
Combination Product (y/n)N
PMA/PMN Number
K091224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDS5100C-US
Device Catalogue NumberDS5100C-US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2019
Date Manufacturer Received10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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