MAUDE Adverse Event Report: MASIMO CORPORATION LNCS ADTX ADHESIVE SENSOR; OXIMETER

Model Number 1859

Device Problem Material Separation (1562)

Patient Problem Death (1802)

Event Date 08/11/2015

Event Type  Death  

Manufacturer Narrative

The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

Event Description

It was reported that nurse mrs.(b)(6) contacted masimo representative and stated that on (b)(6) 2015 a patient needed to be revived after they found him with no vital signs on the bed.At that time the patient was monitored with a ge dash 3000 multi-parameter monitor.According to mrs.(b)(6), the monitor/central station was showing the alarm "sensor disconnected".At this time the patient was monitored with only spo2 with an lncs adt sensor.The patient did refused to be monitored with ecg.The sensor was reported that led and wires were disconnected from the adhesive.The patient was transferred to another hospital (the name of the hospital was not reported) and died after some time.(b)(6) reported to masimo representative that he was the first physician on site after a nurse (name was not mentioned) found the patient with no vital signs.He confirmed the reported situation from mrs.(b)(6).He added the information that when he arrived the sensor was connected to the patient with an exposed led.At the time he arrived at the patient, no alarm was present or displayed.He mentioned that all data records (monitor and central station) were automatically deleted after 48 hours.

Manufacturer Narrative

Lot# updated to k15edm.Returned to manufacturer date updated to 09/04/2015.Added masimo patient cable.The returned sensor was evaluated.The sensor failed visual inspection as the sensor cable was pulling out of the sensor end.This exposes the internal wire jackets and emitter assembly.In this condition, the sensor is unable to engage in patient monitoring.When tested with known good equipment, an error message was displayed on the monitoring device.

• Brand Name: LNCS ADTX ADHESIVE SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 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: charlene johnson ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 5078076
• MDR Text Key: 25831061
• Report Number: 2031172-2015-01084
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1859
• Device Catalogue Number: 1859
• Device Lot Number: K15EDM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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): Death