MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW RC-4; OXIMETER

Model Number	2406
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.(b)(6).
Event or Problem Description
The customer reported intermittently would display values and then suddenly display no values with no errors.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned cable was evaluated.Eeprom content verification did not identify any issues.The cable passed visual inspection no physical damage was observed.The product failed continuity testing due to an open in the cable on the white conductor.Based on the kink in the conductor jacket it is likely the open was a result of the cable being coiled up then pulled straight.When the cable was connected to a masimo monitoring device, the device was able to generate a "sensor off patient" error message.

• Brand Name: RAINBOW RC-4
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6790853
• Report Number: 2031172-2017-00787
• Device Sequence Number: 1760395
• Product Code: DQA
• UDI-Device Identifier: 00843997002295
• UDI-Public: 00843997002295
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080238
• 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

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: 2406
• Device Catalogue Number: 2406
• Device Lot Number: 17APY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 08/12/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1