MAUDE Adverse Event Report: MASIMO - 40 PARKER RD RAINBOW SET R25-12; OXIMETER

Model Number	4078-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the local facility, but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported having difficulties obtaining spo2 readings and fluctuations in the number.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: the returned cable was evaluated.Visual inspection upon receiving revealed no external damage.However, the cable failed continuity tests due to a cut on the yellow conductor jacket; causing exposed solder joint.As a result, the cable has an electrical failure (short) between the yellow conductor and the shield can (outer shield), inside the rd15 connector.The cable failed functional tests and displayed ¿sensor malf¿ error message.Sensor led does not illuminate.Two additional cables from the same lot were returned.The other cables were evaluated and no problem was found.The additional cables passed spo2 simulation tests and were able to obtain spo2 and pulse rate values within normal expected time frame (within 10 seconds)., corrected data: d4 model # was corrected from 4078 to 4078-9.
Event or Problem Description
The customer reported having difficulties obtaining spo2 readings and fluctuations in the number.No patient impact or consequences were reported.

• Brand Name: RD RAINBOW SET R25-12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8207222
• Report Number: 2031172-2018-00598
• Device Sequence Number: 11280187
• Product Code: DQA
• UDI-Device Identifier: 00843997010665
• UDI-Public: 00843997010665
• Combination Product (Y/N): N
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 4078-9
• Device Catalogue Number: 4078
• Device Lot Number: 18EBL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1