• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET DCI; OXIMETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MASIMO - 40 PARKER RD SET DCI; OXIMETER Back to Search Results
Model Number 4050
Device Problems Incorrect Measurement (1383); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2017
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
 
Event Description
The customer reported an interruption of patient monitoring and an extended period of time before the spo2 begins to read.Per the customer, when it does begin to read, it starts very low and then takes an extended time to come up to the expected spo2.The spo2 will then randomly drop-out again with the same behavior as start-up.No consequences or impact to patient were reported.
 
Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned sensor was evaluated.No external physical damage was observed.The sensor failed continuity testing due to multiple broken traces inside the rd15 connector causing multiple open connections.The sensor was connected to a monitor and was unable to obtain readings, the sensor led did not illuminate., corrected data: model # was corrected from 4085-9 to 4050, lot# was corrected from 16jvg to e16jps, catalog # was corrected from 4085 to 4050, udi# corrected from (b)(4) to (b)(4).Corrected from k051212 to k042536.Corrected from 09/09/2016 to 09/01/2016.Corrected from a blank field to rd set ge-12.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RD SET DCI
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.
calzada del oro, no. 2001
parque industrial palaco
mexicali, baja california 21600
MX   21600
Manufacturer Contact
stefan lissmann
52 discovery
irvine, CA 92618-1604
9492977000
MDR Report Key6341919
MDR Text Key67816166
Report Number2031172-2017-00231
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997009805
UDI-Public(01)00843997009805(11)160901(10)16JVG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial,Followup
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
Device Operator Health Professional
Device Model Number4050
Device Catalogue Number4050
Device Lot NumberE16JPS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 01/29/2017
Initial Date FDA Received02/17/2017
Supplement Dates Manufacturer Received07/14/2017
Supplement Dates FDA Received08/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-