MAUDE Adverse Event Report: MEDIANA CO. LTD. NELLCOR

Model Number 10005941JPN

Device Problem No Audible Alarm (1019)

Patient Problem Respiratory Distress (2045)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Patient information as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that alleged the alarm on this unit did not sound.This reportedly occurred during use on a home care patient who was 5 months old.This device was used with a ventilator and was only used at night.The patient was reportedly in respiratory arrest and transported to the hospital.Medtronic has requested additional information regarding the circumstances surrounding the patient event.

• Brand Name: NELLCOR
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KR 00000
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KR 00000
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6407958
• MDR Text Key: 70059334
• Report Number: 2936999-2017-05058
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10005941JPN
• Device Catalogue Number: 10005941JPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2017
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 MO