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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 Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2020
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 device is not reading accurately.No patient impact or consequences were reported.
 
Event Description
The customer reported the device is not reading accurately.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.
 
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Brand Name
RAD-8, HORIZONTAL
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11096375
MDR Text Key224532841
Report Number3011353843-2020-00211
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997005647
UDI-Public00843997005647
Combination Product (y/n)N
PMA/PMN Number
K053269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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