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

Model Number 25052

Device Problems Failure to Charge (1085); Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

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.

Event Description

The customer reported the radical-7 doesn't hold a charge and turns off in the docking station.No consequences or impact to patient were reported.

Event Description

The customer reported the radical-7 doesn't hold a charge and turns off in the docking station.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection found no external defects.During functionality testing, the device loses connection to the dock and the led light indicators on the dock keep blinking, due to the miscommunication with the device.The device would power off because of low battery due to the miscommunication with the device and dock.The sd card was also missing.Internal inspection found multiple pogo pins on the system circuit board were stiff, potentially causing miscommunication with the dock.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event.

• Brand Name: RADICAL-7 HANDHELD
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11780497
• MDR Text Key: 249474616
• Report Number: 3011353843-2021-00105
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: 00843997008358
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

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 Number: 25052
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1