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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD RAINBOW SET MD20-12; OXIMETER
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MASIMO - 52 DISCOVERY RD RAINBOW SET MD20-12; OXIMETER Back to Search Results
Model Number 4073
Device Problem Sensing Intermittently (1558)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/1901
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 intermittently cuts out.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacturing narrative: the returned cable was evaluated.During evaluation the cable passed all visual and functional testing.The cable was determined to be functioning as designed.
 
Event Description
The customer reported the device intermittently cuts out.No patient impact or consequences were reported.
 
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Brand Name
RD RAINBOW SET MD20-12
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11099190
MDR Text Key224533907
Report Number3011353843-2020-00216
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997009744
UDI-Public00843997009744
Combination Product (y/n)N
PMA/PMN Number
K042536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
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 Number4073
Device Catalogue Number4073
Device Lot Number17GJZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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