Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD SET NEO CS-3; 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 - 52 DISCOVERY RD SET NEO CS-3; OXIMETER Back to Search Results
Model Number 4478
Device Problem High Readings (2459)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2020
Event Type  malfunction  
Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow 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 Description
The customer reported the patient's finger spo2 probe was discrepant (6-8 points higher) than abg readings.An attempt was made by rn/rrt to commence forehead prove monitoring; the product was connected to the existing monitoring cable (connections fit together) but we were unable to obtain waveform or red light on device to illuminate.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacturing narrative: other, other text: the device was evaluated.External visual inspection showed sliding neck tape at the sensor end causing the emitter assembly to dislodge from its window.The sensor passed continuity testing, no short or opens were detected when the sensor is manipulated.Functional testing could not be completed as the dislodged emitter assembly prevents the sensor from engaging in monitoring.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: t6g 2b7, corrected data: d1 brand name corrected from lncs tfa-1 to rd set neo cs-3 d4 model # corrected from 3858 to 4478.Catalog # corrected from 3858 to 4478.Lot # updated from a blank field to 20m53.Unique identifier (udi) # updated from a blank field to (b)(4).Expiration date updated from a blank field to 11/01/2023.G5 510(k) corrected from k051439 to k042536.H4 device manufacture date updated from a blank field to 11/05/2020.
 
Event Description
The customer reported the patient's finger spo2 probe was discrepant (6-8 points higher) than abg readings.An attempt was made by rn/rrt to commence forehead prove monitoring; the product was connected to the existing monitoring cable (connections fit together) but we were unable to obtain waveform or red light on device to illuminate.No patient impact or consequences were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RD SET NEO CS-3
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11252236
MDR Text Key229597525
Report Number3011353843-2021-00016
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
PMA/PMN Number
K042536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2023
Device Model Number4478
Device Catalogue Number4478
Device Lot Number20M53
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Was the Report Sent to FDA? No
Date Manufacturer Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-