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

Model Number 22042

Device Problems No Audible Alarm (1019); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection was performed and no external damage or defects were observed.During functional testing, the device did not power on using battery power or ac power and the was found to be unable to charge.Internal inspection isolated the failure to a broken component solder on the system circuit board.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.

Event Description

The customer reported that the device was not holding a charge and not giving a low battery alarm.No consequences or impact to patient 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: stefan lissmann ; 52 discovery; irvine, CA 92618 ; 9492977168
• MDR Report Key: 9387485
• MDR Text Key: 174878929
• Report Number: 3011353843-2019-00130
• 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: K092838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2018
• 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