MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET NK-12 PAT CBLE; OXIMETER

Model Number	4192-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation the cable failed continuity tests using the cirris tester.The solder joints (j1 & j13) cut through the kapton tape; causing exposed solder joints.As a result the cable has a short between the blue conductor (r-cal), inner shield, and shield can (outer shield), inside the rd15 connector.When tested with known good lab equipment the device audibly and visually alarmed, but the sensor led does not illuminate.
Event or Problem Description
Customer reported "low spo2 values with rd nihon kohden cables and cables easily disconnected from sensor".No known impact or consequence to patient.

• Brand Name: RD SET NK-12 PAT CBLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6424196
• Report Number: 2031172-2017-00365
• Device Sequence Number: 735830
• Product Code: DQA
• UDI-Device Identifier: 00843997010726
• UDI-Public: (01)00843997010726(11)160801(10)16H9G
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K050252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• 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: 4192-9
• Device Catalogue Number: 4192
• Device Lot Number: 16H9G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1