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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD TO LNC ADAPTER CABLE; OXIMETER
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MASIMO - 52 DISCOVERY RD TO LNC ADAPTER CABLE; OXIMETER Back to Search Results
Model Number 4105
Device Problem Sensing Intermittently (1558)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2021
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 cable provides intermittent readings.No consequences or impact to patient were reported.
 
Manufacturer Narrative
Additional manufacuring 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 cable provides intermittent readings.No consequences or impact to patient were reported.
 
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Brand Name
RD TO LNC ADAPTER CABLE
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11382001
MDR Text Key233812788
Report Number3011353843-2021-00049
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997010535
UDI-Public00843997010535
Combination Product (y/n)N
PMA/PMN Number
K050252
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4105
Device Catalogue Number4105
Device Lot Number20K73
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PATIENT CABLE; PATIENT CABLE
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