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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD RAINBOW SET R25-12; OXIMETER

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MASIMO - 52 DISCOVERY RD RAINBOW SET R25-12; OXIMETER Back to Search Results
Model Number 4078
Device Problem Sensing Intermittently (1558)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
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 spo2 dropouts during a case.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacturing narrative: other text: the returned device was investigated.Visual inspection found a broken pin at the round 25 pin connector.The device failed continuity tests due to the broken pin causing an open connection.During testing, the cable malfunctioned and the error message "chk sensor" was displayed.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
 
Event Description
The customer reported spo2 dropouts during a case.No patient impact or consequences were reported.
 
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Brand Name
RD RAINBOW SET R25-12
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11064923
MDR Text Key223427773
Report Number3011353843-2020-00209
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 foreign,health professional,u
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/02/2020
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 Number4078
Device Catalogue Number4078
Device Lot Number20JDM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received01/22/2021
Supplement Dates FDA Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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