MAUDE Adverse Event Report: MEDIANA OXIMAX N-560 PULSE OXIMETER

Model Number N-560

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Collapse (2416)

Event Date 08/18/2014

Event Type  Death  

Event Description

It was reported to covidien that patient collapsed and found on the floor face down.Oxymizer was found lying beside the patient groin area on the floor.Pulse ox alarm was not alarming.

Manufacturer Narrative

(b)(4).The serial number was not provided, so the manufacture date is unknown.Several attempts were made to attain additional information, including request for return of the unit for investigation, but those attempts were unsuccessful.

Manufacturer Narrative

Follow up phone call with reporter indicated their investigation indicated device was turned off at the time of event.The patient was reported to have a similar oximeter at home, self cared,adjusted / changed his own therapies from night (bipap) to day oxygen.Facility plans no further investigation.(b)(4).

• Brand Name: OXIMAX N-560 PULSE OXIMETER
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): MEDIANA; wonju industry park; dongwha-ri,munmak-eup, wonju-s; gangwon-do ; KS
• Manufacturer (Section G): MEDIANA; wonju industry park; dongwha-ri,munmak-eup, wonju-si; gangwon-do ; KS
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4136951
• MDR Text Key: 4950004
• Report Number: 2936999-2014-00817
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N-560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• 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
• Treatment: OXYMIZER, BIPAP
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 171