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

Model Number	26818
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.External visual inspection found no damage.The device was unable to power on during functional testing.Internal inspection found the regulator of the system board had failed.Heating was detected while measuring the u7 component of the system board causing the warming of the unit.The customer complaint was duplicated in regard to not powering on, the device does not store log files so the allegation of shutting down during use could not be confirmed.A service history record review reveals that this unit was in the field for over one (1) year with one previously reported issue related to this reported event.
Event or Problem Description
The customer reported the device turned off over night and felt warmer than usual.No patient impact or consequences were reported.

• Brand Name: RAD-5 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11244783
• Report Number: 3011353843-2021-00015
• Device Sequence Number: 14341694
• Product Code: DQA
• UDI-Device Identifier: 00843997005517
• UDI-Public: 00843997005517
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K033296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 26818
• Device Catalogue Number: 9196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2020
• Initial Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1