MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RADICAL-7 HANDHELD; OXIMETER

Model Number 22545

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2021

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found no damage.The device was unable to power on using battery power but powered on when docked into a know good docking station.The unit is unable to charge and does not establish communication with the docking station.Internal inspection found contamination on the j5 pogo pins.The device is unable to be linked to other device due to the contamination on the pogo pins.A service history record review reveals that this unit was in the field for over four (4) years with no previous reported issues related to this reported event.

Event Description

Masimo in bed space y not communicating with the spacelab, thus not communicating with central monitoring system.We checked all the plug connections and even tried replacing them.Removed equipment from service and replaced with masimo from bed space a.Equipment was recognized and removed from service before an adverse event could occur.No patient harm.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 ; 9496978262
• MDR Report Key: 11516886
• MDR Text Key: 242459758
• Report Number: 3011353843-2021-00066
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22545
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• 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