MAUDE Adverse Event Report: MASIMO CORPORATION LNOP INF-L

Model Number LNOP INF-L

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

It was reported that two rad-5v units were used on a newborn infant and gave readings of 0-4% spo2 readings and heart rate 25 bpm.Readings were taken in a hosp room setting, post-labour and after delivery.A spacelabs monitor was also used on the infant and gave values within expectations.The customer confirmed that the spacelabs readings were within the acceptable range for newborns, however, the customer could not provide what the expected range is or what the spacelabs readings were.The customer cannot confirm if the rad-5vs were used on the pt before or after the spacelabs monitor.The model number of the spacelabs unit or other unit identification was not provided.A pt cable pn-2058 was used on each rad-5v when used on the pt.Each rad-5v had an adhesive sensor used on the pt but the sensor info was not available.The customer confirmed that they cannot return the items.No pt injury was reported.No medical intervention was required.

Manufacturer Narrative

Multiple attempts for product return and add'l info requests were made.Per the customer's request, new cables were provided to the customer, however, the device was not made available to masimo to allow an analysis to be performed.If and when info becomes available or once the unit is returned and an eval is performed, a f/u report will be submitted.

• Brand Name: LNOP INF-L
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.; calzada del oro #2001; parque industrial palaco
• Manufacturer Contact: jodi swindle ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 3958126
• MDR Text Key: 4622356
• Report Number: 2031172-2014-00069
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LNOP INF-L
• Device Catalogue Number: 1800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• 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