MAUDE Adverse Event Report: MASIMO CORPORATION RAD-8; OXIMETER

Model Number 20877

Device Problem Electro-Static Discharge (2149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

Event Description

It was reported that the monitors will switch the current to the patient esd risk.There were no consequences or impact to patient reported.

Manufacturer Narrative

The returned device was evaluated.During investigation the equipotential ground screw was found to be slightly loose on the system board which could potentially result in intermittent equipotential ground continuity.The ac power entry module ground pin system board solder joint was broken away from the pin which could potentially result in intermittent ground continuity.Foreign contaminant was also found on the system board, likely caused by liquid ingress.Electrical shorting may have occurred upon liquid ingress.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.

• Brand Name: RAD-8
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 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: charlene johnson ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 5475813
• MDR Text Key: 39524041
• Report Number: 2031172-2016-00261
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K053269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20877
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2008
• 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