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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET INF; OXIMETER
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MASIMO - 40 PARKER RD SET INF; OXIMETER Back to Search Results
Model Number 4002
Medical Device Problem Codes Failure To Adhere Or Bond (1031); Incorrect Measurement (1383)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/16/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product involved in this event has not been returned to date to allow for an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.(b)(6).
 
Event or Problem Description
The customer reported that adhesive quality on rd sensors are not as reliable as previous versions, customer also reporting that rd sensor is reading low sp02.No patient impact or consequences were reported.
 
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Brand Name
RD SET INF
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key6632744
Report Number2031172-2017-00644
Device Sequence Number18959561
Product Code DQA
UDI-Device Identifier10843997009581
UDI-Public10843997009581
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K042536
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Service Personnel
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 Lay User/Patient
Device Model Number4002
Device Catalogue Number4002
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/16/2017
Initial Report FDA Received Date06/10/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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