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

Model Number 25483

Device Problems Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.External visual inspection showed no damage.The device was able to power on using both ac and battery power.When powered on alarm alert conditions with audio and visual status indicators were functioning.The device was not able to obtain readings due to a replace cable error message.The device log was reviewed and no relevant errors were found.Settings such as alarm limits brightness and volume were manually changed and the device was left on in the burn in oven for four hours and no errors were observed and no settings were changed.The technology board was replaced with a known good board and the device was fully functional.The customer complaint was not duplicated in regards to device settings changing back to original setting without input however the complaint of a replace cable error message was duplicated.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 settings changed without anyone interacting with the device.Also the device was providing a replace cable error message.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 1604
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977168
• MDR Report Key: 8982795
• MDR Text Key: 157152081
• Report Number: 3011353843-2019-00055
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/20/2019

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: 25483
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• 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