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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD RAINBOW SET R25-12; OXIMETER
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MASIMO - 52 DISCOVERY RD RAINBOW SET R25-12; OXIMETER Back to Search Results
Model Number 4078
Device Problems Sensing Intermittently (1558); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/1901
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
 
Event Description
The customer reported that the wire is bare at the connection and measurements are interrupted.No consequences or impact to patient were reported.
 
Event Description
The customer reported that the wire is bare at the connection and measurements are interrupted.No consequences or impact to patient were reported.
 
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Brand Name
RD RAINBOW SET R25-12
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11236224
MDR Text Key228973307
Report Number3011353843-2021-00013
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997010665
UDI-Public00843997010665
Combination Product (y/n)N
PMA/PMN Number
K042536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4078
Device Catalogue Number4078
Device Lot Number18H97
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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