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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEO; OXIMETER

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MASIMO - 15750 ALTON PKWY RD SET NEO; OXIMETER Back to Search Results
Model Number 4003
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Pressure Sores (2326)
Event Date 10/24/2022
Event Type  malfunction  
Manufacturer Narrative
Additional manufacuring 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.
 
Event Description
The customer reported "plastic molded to create a pressure point" and "redness." there were no additional medical interventions reported.
 
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Brand Name
RD SET NEO
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 Key16404618
MDR Text Key309997383
Report Number3019388613-2023-00039
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 01/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number4003
Device Catalogue Number4003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/26/2023
Initial Date FDA Received02/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age40 DA
Patient Weight1 KG
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