MAUDE Adverse Event Report: MASIMO - 40 PARKER USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER

Model Number 3577

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

The returned module was evaluated.During evaluation the device passed all visual and functional testing.The module draws power within specification and connected sensor led illuminates and obtains measurement.Module maintains communication with msis and measurement with cable bending.The module was tested for five (5) minutes continuously without loss of signal.X-ray inspection showed no damaged or defect.

Event Description

The customer reported that this cable is working intermittently.No patient impact or consequences were reported.

• Brand Name: USPO2 PULSE OXIMETRY CABLE KIT
• 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: 7279496
• MDR Text Key: 100449985
• Report Number: 2031172-2018-00095
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997007481
• UDI-Public: 00843997007481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121914
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3577
• Device Catalogue Number: 9477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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