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

Model Number 2016

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer 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.(b)(6).

Event Description

The customer reported lnc ge cable # 2016 has intermittent difficulties.Clinician has experienced period where spo2 significantly changes when manipulating patient, hence cable motion.No patient impact or consequences were reported.

Manufacturer Narrative

The returned cable was evaluated.Visual inspection revealed no external physical damage.The cable failed continuity testing due to an open on the white conductor inside the bend relief area of the db9 connector.When connected to a monitor a "probe is off the patient" error message displayed and the unit alarmed audibly and visually.A complaint history review indicates that this lot was in the field for over one (1) years with no previous reported issues related to this reported event.Initial reporter zip code exceeded maximum allowable digits, zip code is as follows: (b)(6).

• Brand Name: LNC-10-GE
• 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: 6666022
• MDR Text Key: 78392667
• Report Number: 2031172-2017-00672
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• 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: 06/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2016
• Device Catalogue Number: 2016
• Device Lot Number: 16AZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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