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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET GE - 12; OXIMETER
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MASIMO - 40 PARKER RD SET GE - 12; OXIMETER Back to Search Results
Model Number 4085-9
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/31/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned cable was evaluated.The cable failed visual inspection due to torn outer jacket along the length of the cable; causing exposed kevlar, wire jackets, and outer shield.During functional evaluation the cable passed all functional testing.The cable was determined to be functioning as designed.A service history record review reveals that this unit was in the field for over eleven (11) months with no previous reported issues related to this reported event., corrected data:.
 
Event or Problem Description
It was reported that there were broken rd ge cables and questionable spo2 values.Returning 6 rd ge 4085 cables.Exposed wires at the sensor connection.No consequences or impact to patient.
 
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Brand Name
RD SET GE - 12
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key6833405
Report Number2031172-2017-00845
Device Sequence Number41509
Product Code DQA
UDI-Device Identifier00843997009805
UDI-Public00843997009805
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K050252
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Health Professional
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 Number4085-9
Device Catalogue Number4085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/15/2017
Initial Report FDA Received Date08/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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