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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RC-4 CABLE; OXIMETER
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MASIMO - 40 PARKER RC-4 CABLE; OXIMETER Back to Search Results
Model Number 2406
Medical Device Problem Code Device Stops Intermittently (1599)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/03/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The returned cable was evaluated and passed the visual inspection.During continuity testing the cable failed due to an open circuit and kink in the conductor jacket.As a result this caused the sensor off patient error message to be displayed intermittently.Failure may have been caused due to cable being coiled up when not in use.(b)(6).
 
Event or Problem Description
The customer reported intermittently would display values and then suddenly display no values with no error message.No patient impact or consequences were reported.
 
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Brand Name
RC-4 CABLE
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key6826271
Report Number2031172-2017-00840
Device Sequence Number68689
Product Code DQA
UDI-Device Identifier00843997002295
UDI-Public00843997002295
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K080238
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
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 Number2406
Device Catalogue Number2406
Device Lot Number16M07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/03/2017
Initial Report FDA Received Date08/29/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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