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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-8, HORIZONTAL; OXIMETER
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MASIMO - 52 DISCOVERY RAD-8, HORIZONTAL; OXIMETER Back to Search Results
Model Number 22042
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/1901
Event Type  malfunction  
Manufacturer Narrative
Additional manufacuring 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 device switches itself off after a while.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacuring 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.
 
Event Description
The customer reported the device switches itself off after a while.No patient impact or consequences were reported.
 
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Brand Name
RAD-8, HORIZONTAL
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11175066
MDR Text Key227011890
Report Number3011353843-2021-00009
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997005647
UDI-Public00843997005647
Combination Product (y/n)N
PMA/PMN Number
K053269
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 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number22042
Device Catalogue Number9190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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