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

Model Number 2056

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2017

Event Type  malfunction  

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 Description

The customer reported cable not working intermittently or readings are weak.No patient impact or consequences were reported.

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
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.; calzada del oro, no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6806465
• MDR Text Key: 83100027
• Report Number: 2031172-2017-00797
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997011709
• UDI-Public: 00843997011709
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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

• Date FDA Received: 08/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1