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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G PULSE OXIMETER (WITH PATIENT CABLE)
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MASIMO - 15750 ALTON PKWY RAD-G PULSE OXIMETER (WITH PATIENT CABLE) Back to Search Results
Model Number 27977
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2023
Event Type  malfunction  
Event Description
The customer reported the device shuts itself on and off.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.The failure analysis determined that the device powered on and off due to an electrically shorted component on the circuit board.
 
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Brand Name
RAD-G PULSE OXIMETER (WITH PATIENT CABLE)
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 15750 ALTON PKWY
15750 alton pkwy
irvine CA 92618
Manufacturer (Section G)
MASIMO - MEXICALI
industrial vallera de mexicali calzada del oro, no.2001
mexicali, baja california 21600
MX   21600
Manufacturer Contact
tahereh sedighi
15750 alton pkwy
irvine, CA 92618
9492977862
MDR Report Key17044539
MDR Text Key316417512
Report Number3019388613-2023-00147
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997000666
UDI-Public00843997000666
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 05/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number27977
Device Catalogue Number9849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2022
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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