MAUDE Adverse Event Report: MEDIANA LIBRA BEDSIDE SPO2 MONITOR; PULSE OXIMETRY

Model Number 10005941

Device Problem No Audible Alarm (1019)

Patient Problem Death (1802)

Event Date 11/24/2016

Event Type  Death  

Manufacturer Narrative

Covidien/medtronic reference number: (b)(4).Patient information (id, age, sex, weight) has been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.Medtronic is attempting to gather additional information surrounding the circumstances associated to this event.

Event Description

Medtronic received a report the bedside spo2 monitor did not generate an audible alarm.Customer confirmed the expired although the date of patient death was not reported.Follow up efforts are being made to gather additional information surrounding the circumstances of the customer reported event.

• Brand Name: LIBRA BEDSIDE SPO2 MONITOR
• Type of Device: PULSE OXIMETRY
• Manufacturer (Section D): MEDIANA; wonju industry park; dongwha-ri,munmak-eup wonju-si; gangwon-do ; KS
• Manufacturer (Section G): MEDIANA; wonju industry park; dongwha-ri,munmak-eup wonju-si; gangwon-do
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6197461
• MDR Text Key: 63048321
• Report Number: 2936999-2016-01088
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K120773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10005941
• Device Catalogue Number: 10005941
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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
• Patient Outcome(s): Death