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

Model Number 26818

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2020

Event Type  malfunction  

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 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
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 52 discovery; irvine, CA 92618 ; 9496978262
• MDR Report Key: 11244783
• MDR Text Key: 229657339
• Report Number: 3011353843-2021-00015
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997005517
• UDI-Public: 00843997005517
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K033296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1