MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET PATIENT CABLE; OXIMETER

Model Number	4083
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2016
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., additional manufacturing narrative (if other): initial customer address exceeded maximum allowable digits, address is as follows: (b)(6).Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
Event or Problem Description
It was reported that loose connection at monitor plug.If you move the cable at the round plug, there is sporadically no more curve.Per the customer, there was a measurement in the beginning, but further on the artifacts increased, the measurement disappeared.No known impact or consequence to patient.
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation the cable failed continuity tests as the solder joint (j2) was found cut through the kapton tape causing an exposed solder joint.As a result, the cable has a short between the white (detector anode) and the shield can (outer shield), inside the rd15 connector.When the cable was tested with a known good philips fast monitor and sensor a ¿sensor malf" error message displayed.(b)(6).A service history record review reveals that this unit was in the field for over six (6) months with no previous reported issues prior to this reported event.

• Brand Name: RD SET PATIENT CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6141955
• Report Number: 2031172-2016-01363
• Device Sequence Number: 223917
• Product Code: DQA
• UDI-Device Identifier: 00843997009782
• UDI-Public: (01)00843997009782(11)160701(10)16H45
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K050252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup

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: No Information
• Device Model Number: 4083
• Device Catalogue Number: 4083
• Device Lot Number: 16H45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1