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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY LNCS NEOPT; OXIMETER
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MASIMO - 52 DISCOVERY LNCS NEOPT; OXIMETER Back to Search Results
Model Number 23210
Device Problems Loss of or Failure to Bond (1068); Sensing Intermittently (1558); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
 
Event Description
The customer reported the sensor glue was easily dissolved after only a few hours of use, also the cable protection was falling off quickly so that the wires were exposed and the measuring was partly interrupted.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacturing narrative: other text: the returned sensors were evaluated.Visual inspection found sliding neck tape at sensor end; causing exposed conductor jackets and shields.During continuity tests; no short or open was detected, and no intermittent short or open was detected when manipulated.The devices are functioning electrically as designed.The sensors were tested with a lab cable for 15 minutes continuously and no problem was found, able to obtain spo2 and pulse rate values throughout the entire 15 minutes of testing., corrected data: d4.Model # updated from "2330" to "23210", d4.Lot # updated from "2j388" to "a12j388".
 
Event Description
The customer reported the sensor glue was easily dissolved after only a few hours of use, also the cable protection was falling off quickly so that the wires were exposed and the measuring was partly interrupted.No patient impact or consequences were reported.
 
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Brand Name
LNCS NEOPT
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11387090
MDR Text Key234100144
Report Number3011353843-2021-00051
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
PMA/PMN Number
K060143
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number23210
Device Catalogue Number2330
Device Lot NumberA12J388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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