MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS NEO-3; OXIMETER

Model Number 2320

Device Problems Failure To Adhere Or Bond (1031); Incorrect Measurement (1383); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2017

Event Type  Injury  

Manufacturer Narrative

Additional manufacuring 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): corrected data:.

Event Description

The customer reported, i work with vent patients and i have a few complaints about your masimo pulse oximerty probes, especially the lncs neo-3.The probe comes in a package that is difficult to open in an emergency as well as it comes where it is coiled in a manner that you have to pause, untie the thing, then unravel it or you'll get knots.Then the adhesive strip is abysmal- it will stick to itself and cause issues if you do not put it on slowly, and in a case of emergency i know of a few nurses who have had to resort to multiple probes because the adhesive strip folded in on itself as we're trying to put the probe on a pediatric patient in distress and we had to start over again.The design of your probe is also lacking.There's a weak spot from the cross strip that is placed on a finger or a toe to the main wire and if the probe is on a the patient's foot it is possible for those wires to wear down and break before the time that the doctor suggests to change the probe.This can be dangerous as in home health we only get a limited amount of supplies by our equipment company and every malfunctioning or busted probe is not replaced.I have also had several probes in the past month fail within 24-48 hours if initial use.The most recent one failed tonight- a malfunctioning probe which could not accurately read the patient's oxygen saturation.This led to a possible unnecessary administration of breathing treatments and other interventions, all which could have been avoided if the probe was working properly.I replaced what appeared to be a "working" probe and got a totally different reading.This poor quality control can actually harm the children i work with as they are already medically fragile and bad equipment can exacerbate their conditions.It's bad enough that this equipment is expensive.But to have most of it fail or not be durable enough to last more than 48 hours is insulting.I am very displeased with the current output of your product and will look to your competitors for an alternative if this poor quality persists.

Manufacturer Narrative

Corrected data: (report date) was updated from "01/16/2017" to "01/17/2017".

• Brand Name: LNCS NEO-3
• 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: 6310718
• MDR Text Key: 66806697
• Report Number: 2031172-2017-00162
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2320
• Device Catalogue Number: 2320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other