MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-8, HORIZONTAL; OXIMETER

Model Number 22042

Device Problems Inappropriate or Unexpected Reset (2959); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.External visual inspection showed the shell was damaged.The device was able to power on using both ac and battery power.When powered on the device was able to obtain readings and alarmed audibly and visually under alarm conditions.The unit would unexpected restart after approximately 10 minutes.Internal inspection found the issue was related to the system board.C200 on the system board is damaged and the u6 chip on the board has failed.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.

Event Description

The customer reported the device has a cracked case and shuts itself off.No patient impact or consequences were reported.

• Brand Name: RAD-8, HORIZONTAL
• 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: 11276460
• MDR Text Key: 230727452
• Report Number: 3011353843-2021-00018
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997005647
• UDI-Public: 00843997005647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053269
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 22042
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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