MAUDE Adverse Event Report: MASIMO - 40 PARKER RED LNC-10 CABLE; OXIMETER

Model Number	2056
Medical Device Problem Codes	Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2017
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.(b)(6).
Event or Problem Description
The customer reported cable not working intermittently or readings are weak.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned cable was evaluated.During evaluation the cable passed all visual and functional testing.Eeprom content verification did not identify any issues.The cable was determined to be functioning as designed.Initial reporter zip code exceeded the maximum number of allowable digits, the zip code is as follows: (b)(6).Corrected data: udi # updated (b)(4).

• Brand Name: RED LNC-10 CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6806465
• Report Number: 2031172-2017-00797
• Device Sequence Number: 1077816
• Product Code: DQA
• UDI-Device Identifier: 00843997011709
• UDI-Public: 00843997011709
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• 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: 2056
• Device Catalogue Number: 2056
• Device Lot Number: 16K4B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 08/19/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1