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

Model Number	3577
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer 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 an intermittent connection.No patient impact or consequences were reported.
Event or Problem Description
The customer reported an intermittent connection.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed a damaged ch stress relief and the latch is missing.The device failed functional testing, it does not draw power or communicate with the test fixture when the cable is bent.Discontinuity was measured on the wire when the cable was bent.A service history record review reveals that this unit was in the field for over ten (10) months with no previous reported issues related to this reported event.

• 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: 10898453
• Report Number: 3011353843-2020-00189
• Device Sequence Number: 11096815
• 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: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1