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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY KIT, RADIUS-7; OXIMETER
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MASIMO - 52 DISCOVERY KIT, RADIUS-7; OXIMETER Back to Search Results
Model Number 24949
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/1901
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.
 
Event Description
The customer reported the device glitches and periodically disconnects.No patient impact or consequences were reported.
 
Event Description
The customer reported the device glitches and periodically disconnects.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacturing 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.
 
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Brand Name
KIT, RADIUS-7
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11975359
MDR Text Key255423429
Report Number3011353843-2021-00132
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997009249
UDI-Public00843997009249
Combination Product (y/n)N
PMA/PMN Number
K140188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24949
Device Catalogue Number9664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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