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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER KIT, RADIUS-7; OXIMETER
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MASIMO - 40 PARKER KIT, RADIUS-7; OXIMETER Back to Search Results
Model Number 24970
Medical Device Problem Codes Unable to Obtain Readings (1516); Sensing Intermittently (1558)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/28/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.
 
Event or Problem Description
The customer reported they started the test and in a few seconds the device stopped giving a reading, the pulse curve drastically dropped, as did the spo2 curve and ip.No patient impact or consequences were reported.
 
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Brand Name
KIT, RADIUS-7
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key7449930
Report Number2031172-2018-00242
Device Sequence Number19148406
Product Code DQA
UDI-Device Identifier00843997009249
UDI-Public00843997009249
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K153225
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 Other
Device Model Number24970
Device Catalogue Number9664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2018
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/29/2018
Initial Report FDA Received Date04/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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