MAUDE Adverse Event Report: MASIMO - 40 PARKER RED DCI-DC3; OXIMETER

Model Number	2053
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2017
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 that the sensor does not read spo2 consistently and the wires attached to finger part are frayed.Additional information indicated the product would display values and then suddenly display no values.The product would work if the lead was jiggled sometimes, but sometimes not.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
The returned sensor failed visual analysis due to a torn bend relief at the sensor end.The sensor failed continuity testing due to a short in the cable between the white conductor and inner shield at the torn bend relief area.As a result the sensor functioned intermittently.When the intermittent connection was held in normal operation and then manipulated to "open" (non-functional) condition, the device to which it was connected went into alarm condition (audibly and visually alarmed), readings zeroed out, pleth went flat, and ¿sensor off patient" error message displayed.

• Brand Name: RED DCI-DC3
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7203130
• Report Number: 2031172-2018-00022
• Device Sequence Number: 16357161
• Product Code: DQA
• UDI-Device Identifier: 00843997001236
• UDI-Public: 00843997001236
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• 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: Health Professional
• Device Model Number: 2053
• Device Catalogue Number: 2053
• Device Lot Number: 17E98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1