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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY ROOT; OXIMETER
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MASIMO - 15750 ALTON PKWY ROOT; OXIMETER Back to Search Results
Model Number 26224
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2022
Event Type  malfunction  
Event Description
The customer reported the speaker does not work correctly.No consequences or impact to patient were reported.
 
Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
 
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Brand Name
ROOT
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 Key15921220
MDR Text Key304873229
Report Number3019388613-2022-00259
Device Sequence Number1
Product Code MWI
UDI-Device Identifier00843997014168
UDI-Public00843997014168
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial
Report Date 11/09/2022
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 Number26224
Device Catalogue Number9905
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/09/2022
Initial Date FDA Received12/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2019
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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