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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-87; OXIMETER
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MASIMO - 40 PARKER RAD-87; OXIMETER Back to Search Results
Model Number 21649
Medical Device Problem Code No Audible Alarm (1019)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/02/2017
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
It was reported that device "does not alarm when the battery is about to die".Per the customer, the unit failed to alarm and did not provide an error message or alarm before it turned off.No known impact or consequence to patient was reported.
 
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Brand Name
RAD-87
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key6583350
Report Number2031172-2017-00589
Device Sequence Number616441
Product Code DQA
UDI-Device Identifier00843997005609
UDI-Public00843997005609
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K091241
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 Number21649
Device Catalogue Number9226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/02/2017
Initial Report FDA Received Date05/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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