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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RD RAINBOW SET MD20 - 12; OXIMETER
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MASIMO - 40 PARKER RD RAINBOW SET MD20 - 12; OXIMETER Back to Search Results
Model Number 4073-9
Medical Device Problem Codes Break (1069); Incorrect Measurement (1383); Device Stops Intermittently (1599)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/26/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: the returned cable was evaluated.During evaluation the cable passed all functional testing, including spo2 and pulse rate simulation tests.The returned cable failed visual analysis due to cut on the outer jacket along the length of the cable.The cable was otherwise determined to be functioning as designed.
 
Event or Problem Description
The customer reported the cable is splitting at the sensor connection end, causing intermittent readings, dropping out signals, and over issues with effective and accurate monitoring.No patient impact or consequences were reported.
 
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Brand Name
RD RAINBOW SET MD20 - 12
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key7281004
Report Number2031172-2018-00102
Device Sequence Number13765750
Product Code DQA
UDI-Device Identifier00843997009744
UDI-Public00843997009744
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K042536
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number4073-9
Device Catalogue Number4073-9
Device Lot Number17BSD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2018
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/26/2018
Initial Report FDA Received Date02/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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