MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET NEO; OXIMETER

Model Number 4003

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 03/13/2017

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.

Event Description

It was reported that the mother was returning the patient to the crib when she stated that she was either poked or shocked by the spo2 probe.The sensor was visibly damaged at the ribbon area.There was no liquid in the area.The mother and baby are both fine.No consequences or impact to patient.

Manufacturer Narrative

The returned sensor was evaluated.External inspection shows damaged foam causing exposed flex cable.The sensor passed continuity testing with no short or open detected.The sensor functioned as designed when connected to a radical-7.Additional testing was performed on the exposed flex cable area, however no shock was able to be produced.A service history record review reveals that this lot was in the field for over three (3) months with no previous reported issues related to this reported event., corrected data:.

• Brand Name: RD SET NEO
• 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: 6449311
• MDR Text Key: 71376079
• Report Number: 2031172-2017-00390
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: (01)10843997009598(17)200201(10)17BBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• 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: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4003
• Device Catalogue Number: 4003
• Device Lot Number: 17BBX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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