MAUDE Adverse Event Report: MASIMO - 40 PARKER RD RAINBOW SET MD20 - 12; OXIMETER

Model Number 4073-9

Device Problems Break (1069); Incorrect Measurement (1383); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

The returned cable was evaluated.During evaluation the cable passed all functional testing, including spo2 and pulse rate simulation tests.The returned cable failed visual analysis due to a torn outer jacket at the bend relief area of the rd15 connector.The torn outer jacket was most likely due to cleaning solution based upon the stiffness/hardness of the outer jacket at the torn area.The cable was otherwise determined to be functioning as designed.

Event Description

The customer reported the cable is splitting at the sensor connection end, causing intermittent readings, dropping out signals, and over issues with effective and accurate monitoring.No patient impact or consequences were reported.

• Brand Name: RD RAINBOW SET MD20 - 12
• 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: 7281003
• MDR Text Key: 100535630
• Report Number: 2031172-2018-00101
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997009744
• UDI-Public: 00843997009744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042536
• 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: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4073-9
• Device Catalogue Number: 4073-9
• Device Lot Number: 17BSD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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