MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER

Model Number	3577
Medical Device Problem Codes	Incorrect Measurement (1383); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported the cable is coming apart at the sleeve, leaving a gap with visible wire and is giving inaccurate o2 readings.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.During evaluation the device passed all functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.No product performance issue related to spo2 and pulse rate was identified.The device had a damaged stress relief, but it was not found to impact functionality.A service history record review reveals that this unit was in the field for over nine (9) months with no previous reported issues prior to this reported event.
Event or Problem Description
The customer reported the cable is coming apart at the sleeve, leaving a gap with visible wire and is giving inaccurate o2 readings.No patient impact or consequences were reported.

• Brand Name: USPO2 PULSE OXIMETRY CABLE KIT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9630164
• Report Number: 3011353843-2020-00004
• Device Sequence Number: 3168868
• Product Code: DQA
• UDI-Device Identifier: 00843997007481
• UDI-Public: 00843997007481
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 3577
• Device Catalogue Number: 3577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1