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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 Problems Device Alarm System (1012); Disconnection (1171); Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 04/01/2020
Event Type  Death  
Manufacturer Narrative
Additional manufacturing narrative: the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
 
Event Description
The customer reported a patient had expired while connected to our monitors.Per the reported issue, the customer alleged a notification was not sent to them.However the customer also reported the device alerted the system with a message of "no comm" multiple times and "sensor off" message.".
 
Event Description
The customer reported the device alerted the system with a message of "no comm" multiple times and "sensor off" message.The customer also reported a patient had expired while connected to the monitors and a notification was not sent to them.
 
Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.No external damage or defects were observed during visual inspection.During functional testing, the unit intermittently lost communication with a known good radical docking station.During internal inspection, it was determined that the communication issue may be related to pogo pins that were not moving freely.The pogo pins were not moving freely due to contamination found on the pins, which resulted in the pins partially sticking against the pin barrel and not freely springing back to their extended position.The concomitant products which include the radical docking station and patient safetynet system were investigated and both were found to be functioning as designed.The patient safetynet report was reviewed and it was confirmed that the appropriate messages identifying communication loss between the bedside monitor and patient safetynet system were delivered to the customer facility's notification management system.Masimo is unable to confirm the functionality of the non-masimo notification system.A service history record review reveals that this unit was in the field for over four (4) years with no previous reported issues related to this reported event., corrected data: description of the event was updated from: "the customer reported a patient had expired while connected to our monitors.Per the reported issue, the customer alleged a notification was not sent to them.However the customer also reported the device alerted the system with a message of 'no comm' multiple times and 'sensor off' message." to: "the customer reported the device alerted the system with a message of 'no comm' multiple times and 'sensor off' message.The customer also reported a patient had expired while connected to the monitors and a notification was not sent to them.".
 
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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 Key10018011
MDR Text Key189617983
Report Number3011353843-2020-00063
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 company representative,user f
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25054
Device Catalogue Number9500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/02/2020
Initial Date FDA Received05/01/2020
Supplement Dates Manufacturer Received07/15/2020
Supplement Dates FDA Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PATIENT SAFETYNET; RDS-3; PATIENT SAFETYNET; RDS-3
Patient Outcome(s) Death;
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