MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-5V PULSE OXIMETER

Model Number 25199

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

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.Device not returned.

Event Description

The customer reported the device display shows incorrect values.No patient impact or consequences were reported.

Event Description

The customer reported the device display shows incorrect values.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated and passed visual inspection and functionality testing.Simulation tests were performed and no product performance issue identified related to spo2 and pulse rate.Additionally, the device was placed in the burn-in oven with a tester for an hour.No issues were observed with the display or measurements.Internal inspection found contamination on the system board; however the reported issue was not duplicated.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.

• Brand Name: RAD-5V PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11316059
• MDR Text Key: 231680409
• Report Number: 3011353843-2021-00029
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (y/n): N
• PMA/PMN Number: K033998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25199
• Device Catalogue Number: 9197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1