MAUDE Adverse Event Report: COVIDIEN NELLCOR; MAX NEO O2 SENSOR, N25

Model Number MAX-NI

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591)

Patient Problem Shock (2072)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The sensor reported was discarded and not available for investigation.The customer did not retain the sensor's lot number.The date of manufacture cannot be determined.The (b)(4) service and repair centre customer service engineer (cse) performed testing and analysis of the pm100n bedside spo2 patient monitor sn (b)(4).The unit passed all verification checks, electrical safety tests and performed as intended.No faut was found with this unit.

Event Description

The customer reported that following surgery, the child was monitored for approximately 4- 5 hours.The monitor alarm was annoying child and the alarm limits were reset.It was reported the child experienced a pulsating sensation in his right thumb and received electric shock.The electric shock frightened the child and he removed the probe.The child no longer required monitoring so the nurse removed the monitor and called the surgical doctor who ordered a priority ecg, bloods and a pediatric review.The child was seen and assessed by the surgical doctor and pediatric doctor and discharged home the following morning.

• Brand Name: NELLCOR
• Type of Device: MAX NEO O2 SENSOR, N25
• Manufacturer (Section D): COVIDIEN; blvd. insurgentes parcela #37; tijuana, bc 22570 ; MX 22570
• Manufacturer (Section G): COVIDIEN; blvd. insurgentes parcela #37; tijuana bc ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5748760
• MDR Text Key: 48144624
• Report Number: 2936999-2016-00519
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K052186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAX-NI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• 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
• Treatment: PM100N BEDSIDE SPO2 PATIENT MONITOR SN (B)(4)
• Patient Outcome(s): Required Intervention