MAUDE Adverse Event Report: MASIMO - 40 PARKER RADICAL-7; OXIMETER

Model Number 25052

Device Problems Failure To Run On AC/DC (1001); No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

When the investigation is complete a follow up report will be submitted.

Event Description

The customer reported switches off itself during a patient's treatment, no alert.The lights on the front panel will blink, and device will not start up after that.No patient impact or consequences were reported.

Manufacturer Narrative

The returned device was evaluated.Visual inspection found no internal circuitry damage or loose connections.The battery was missing from the device which caused the light on the front panel to blink.A known functioning battery installed and the radical-7 was able to power on.The device was able to be charged with the rds-3 and obtain readings.The device was tested using power supplies on the circuit board and found the (u10) chip failed when only using ac power.The customer complaint was duplicated.The device could not turn on due to a malfunction on the power supply chip (u10) failure on the system circuit board.A service history record reveals that this unit has been in the field for over (7) seven months with (1) one other reported issue related to this event.(report source) was updated from ¿foreign; health professional; user facility" to ¿ foreign; company representatives; user facility" (device manufacture date) was updated from ¿02/22/2017" to ¿02/21/2017".

• Brand Name: RADICAL-7
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.; calzada del oro, no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: erica kline ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6837254
• MDR Text Key: 84308165
• Report Number: 2031172-2017-00847
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• 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: 08/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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
• Treatment: RDS-3 DOCKING STATION V2