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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-8, HORIZONTAL; OXIMETER
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MASIMO - 52 DISCOVERY RAD-8, HORIZONTAL; OXIMETER Back to Search Results
Model Number 22042
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2019
Event Type  malfunction  
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.
 
Event Description
The customer reported the rad-8 device had a speaker failure, no sound when alarming.No patient impact or consequences were reported.
 
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Brand Name
RAD-8, HORIZONTAL
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618 1604
Manufacturer (Section G)
MASIMO - MEXICALI
industrial vallera de mexicali calzada del oro, no.2001
mexicali, baja california 21600
MX   21600
Manufacturer Contact
stefan lissmann
52 discovery
irvine, CA 92618-1604
9492977168
MDR Report Key8869992
MDR Text Key153862538
Report Number3011353843-2019-00027
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997005647
UDI-Public00843997005647
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K092838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number22042
Device Catalogue Number9190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2016
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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