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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET MP - 12; OXIMETER
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MASIMO - 40 PARKER RD SET MP - 12; OXIMETER Back to Search Results
Model Number 4083-9
Medical Device Problem Code Device Stops Intermittently (1599)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/01/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
During evaluation, the cable passed visual inspection; eeprom contents were verified and no problems were observed through this verification; however, failed functional analysis due to broken solder joints on the red and orange conductors inside the rd15 connector.A ¿sensor malf" error message displayed; which would have prevented the unit from being able to engage in monitoring activities.
 
Event or Problem Description
The customer reported cable works intermittently.No known impact or consequence to patient was reported.
 
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Brand Name
RD SET MP - 12
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key6888960
Report Number2031172-2017-00898
Device Sequence Number809947
Product Code DQA
UDI-Device Identifier00843997009782
UDI-Public00843997009782
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K050252
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
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 Number4083-9
Device Catalogue Number4083
Device Lot Number16KHE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2017
Initial Report FDA Received Date09/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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