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 Consequences Or Impact To Patient (2199)

Event Date 01/02/2021

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 unit is not charging and is shutting down automatically.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found no damage or defects.The unit did not power on and off using battery power but was able to power on and off using ac power.A 10 beep watchdog alarm was triggered after boot up.The device was unable to take measurements and the screen went dark while it beeped.Customer's battery was not recognized by the device.A known good battery was temporarily installed, and the device is able to charge the battery and power on using battery power.Internal inspection found a short that causes the voltages in the instrument board to be out of range.A component of the instrument board was found to be defective causing the device to trigger a watchdog alarm that powers off the display and the device does not charge the battery due to a defective battery.A service history record review reveals that this unit was in the field for over seven (7) years with no previous reported issues related to this reported event.

Event Description

The customer reported the unit is not charging and is shutting down automatically.No patient impact or consequences were reported.

• Brand Name: RADICAL-7 HANDHELD
• 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 ; 9498223661
• MDR Report Key: 11378957
• MDR Text Key: 233555254
• Report Number: 3011353843-2021-00045
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: K110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• 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