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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G PULSE OXIMETER
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MASIMO - 15750 ALTON PKWY RAD-G PULSE OXIMETER 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 02/07/2023
Event Type  malfunction  
Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.A shorted power button on the circuit board resulted in the rad-g powering on and off by itself.
 
Event Description
The customer reported the rad-g "will power off on its own and and powers on." no patient impact or consequences were reported.
 
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Brand Name
RAD-G PULSE OXIMETER
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
matofa fautua
15750 alton pkwy
irvine, CA 92618
9498223661
MDR Report Key16475216
MDR Text Key310623465
Report Number3019388613-2023-00052
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 Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 02/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2023
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 Manufacturer02/10/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2022
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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