MAUDE Adverse Event Report: MASIMO - 40 PARKER USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER

Model Number	3578
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2019
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.
Event or Problem Description
The customer reported the cable has an intermittent operation; any slight movement of the cable causes a disconnect.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned module was evaluated.Visual inspection upon receiving revealed no external defect or damage.The module failed functional testing due to broken wires inside the fh bend relief connector and inside the fh connector.The broken wires result in loss of functionality.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues prior to this reported event.
Event or Problem Description
The customer reported the cable has an intermittent operation; any slight movement of the cable causes a disconnect.No patient impact or consequences were reported.

• Brand Name: USPO2 PULSE OXIMETRY CABLE KIT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8637569
• Report Number: 2031172-2019-00263
• Device Sequence Number: 16667016
• Product Code: DQA
• UDI-Device Identifier: 00843997007498
• UDI-Public: 00843997007498
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/03/2019

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: 3578
• Device Catalogue Number: 3578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1