MAUDE Adverse Event Report: MASIMO CORPORATION USPO2 PULSE OXIMETRY CABLE KIT

Model Number 9477

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Electric Shock (2554)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

It was reported that while wearing an apexpro fh with a disposable spo2 sensor, pt experienced a shock.Customer reported that as pt was washing her hands under running water with the sensor connected to her finger, and sensor plugged into the probe box, she felt a shock.It was reported that the nurse took the transmitter and spo2 cable out of service immediately.It was reported that about thirty minutes after the event, the pt complained of "tingling" still in her right middle finger.There was no med intervention required.

Manufacturer Narrative

Multiple attempts for product return and requests for additional info were made.The product has not been returned to masimo to allow an analysis to be performed.If new info is obtained or the product is returned, a follow up report will be submitted.

• Brand Name: USPO2 PULSE OXIMETRY CABLE KIT
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A.
• Manufacturer Contact: charlene johnson ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4593631
• MDR Text Key: 5629842
• Report Number: 2031172-2015-00332
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9477
• Device Catalogue Number: 9477
• Device Lot Number: SEZ14433596GA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1