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

Model Number	4078-9
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned cable was evaluated.Eeprom content verification did not identify any issues.When the cable was connected to a masimo monitoring device, the device was able to generate a "no sensor" error message.Visual inspection revealed multiple broken pins at the round 25 pin connector.The cable failed continuity testing.The failure was isolated to the broken pins on the pin connector which resulted in multiple open connections.
Event or Problem Description
The customer reported: "was told by rn haley that the monitor in room 448 sporadically loses the spo2 reading.She changed cables twice during her shift to get it to work.I have the 2 cables from the specific room but not any sensors.As tasked by leadership, i am to pull the cable and send it for failure analysis.Unfortunately the rn did not save the sensor.Logs were pulled and i didn't see any dropouts, just large desats." 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: 7170902
• Report Number: 2031172-2018-00007
• Device Sequence Number: 1210532
• Product Code: DQA
• UDI-Device Identifier: 00843997010665
• UDI-Public: 00843997010665
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 4078-9
• Device Catalogue Number: 4078
• Device Lot Number: 17DDT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 70