MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RADICAL-7 HANDHELD; OXIMETER

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.".

• Brand Name: RADICAL-7 HANDHELD
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10018011
• MDR Text Key: 189617983
• Report Number: 3011353843-2020-00063
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K110028
• Number of Events Reported: 1
• 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 Number: 25054
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT SAFETYNET; RDS-3; PATIENT SAFETYNET; RDS-3
• Patient Outcome(s): Death