MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW R1 25L; OXIMETER

Model Number	2414-8
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.Eeprom content verification did not identify any issues.The sensor failed visual inspection due to a broken latch on the m15 connector.The unit failed continuity testing due to an open connection on the diode 10 at the solder joint assembly.The reported issue was confirmed.When the sensor was connected to a masimo monitoring device, the device was able to generate a "replace sensor" error message.Initial reporter zip code exceeded the maximum number of allowable digits, zip code is as follows (b)(6).
Event or Problem Description
The customer reported it could get the value at first, however the sensor could no longer blink or obtain values during the monitoring.No patient impact or consequences were reported.

• Brand Name: RAINBOW R1 25L
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6910927
• Report Number: 2031172-2017-00924
• Device Sequence Number: 711524
• Product Code: DQA
• UDI-Device Identifier: 10843997002322
• UDI-Public: 10843997002322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• 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 Expiration Date: 06/01/2020
• Device Model Number: 2414-8
• Device Catalogue Number: 2414
• Device Lot Number: 17FYU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1