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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-5V PULSE OXIMETER
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MASIMO - 40 PARKER RAD-5V PULSE OXIMETER Back to Search Results
Model Number 25199
Medical Device Problem Code Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/06/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation the device passed all visual and functional testing.All the led segments on the led digits fully illuminated upon start up.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning correctly.(b)(6).
 
Event or Problem Description
The customer reported that the segments for spo2 and pr are sometimes missing.No consequences or impact to patient were reported.
 
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Brand Name
RAD-5V PULSE OXIMETER
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key7921231
Report Number2031172-2018-00488
Device Sequence Number16557634
Product Code DQA
UDI-Device Identifier00843997005524
UDI-Public00843997005524
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K033998
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 09/06/2018
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 Number25199
Device Catalogue Number9197
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/06/2018
Initial Report FDA Received Date09/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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