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

Model Number	4073-9
Medical Device Problem Codes	Break (1069); Incorrect Measurement (1383); Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7281003
• Report Number: 2031172-2018-00101
• Device Sequence Number: 956912
• Product Code: DQA
• UDI-Device Identifier: 00843997009744
• UDI-Public: 00843997009744
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1