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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RADICAL-7 HANDHELD; OXIMETER
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MASIMO - 52 DISCOVERY RADICAL-7 HANDHELD; OXIMETER Back to Search Results
Model Number 25054
Device Problem Device Alarm System (1012)
Patient Problem Death (1802)
Event Date 09/06/2020
Event Type  Death  
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 patient was found unresponsive in bed.The radical-7 was not alarming at that time.The nurse reported it had dashes.The responder 5 nurse call system did not activate and the bernoulli system also did not alarm.
 
Manufacturer Narrative
Additional manufacturing narrative:other text: the device was returned and investigated.External visual inspection found no damage or defects.The device was returned without the sd card, so when powered on a "no sd card" error is provided, in this condition the device cannot function.A known good sd card was used for testing.The device was able to power on using both ac and battery power.When powered on the device was able to obtain readings and alarmed audibly and visually under alarm conditions.The nurse call functionality was functioning as designed.The trend data was successfully downloaded but the reported date of event was not included as the customer's sd card was not returned with the device.The device was determined to be functioning as designed., corrected data: d4 model # updated from 9500 to 25054.
 
Event Description
The customer reported the patient was found unresponsive in bed.The radical-7 was not alarming at that time.The nurse reported it had dashes.The responder 5 nurse call system did not activate and the bernoulli system also did not alarm.
 
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Brand Name
RADICAL-7 HANDHELD
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key10657920
MDR Text Key210680916
Report Number3011353843-2020-00157
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
PMA/PMN Number
K110028
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 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number25054
Device Catalogue Number9500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Was the Report Sent to FDA? No
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RDS-1; RDS-1
Patient Outcome(s) Death;
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