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

Model Number N-560

Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

It was reported that during use the reading became "o:o", but no alarms was generated.Also the reading of the sat-message displayed "0:0".After the incident, the device was used on another patient without problem.The reported condition was not duplicated.There was no pt harm reported.

Manufacturer Narrative

Covidien reference (b)(4).

Manufacturer Narrative

Covidien refreernce number: the printed circuit board (pcb) from the n560 monitor was returned.Failure investigation verified the customer complaint.This product is no longer manufactured.

• Brand Name: OXIMAX N-560 PULSE OXIMETER
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): MEDIANA; monju industry park; dongwha-ri, munmak-eup; gangwon ; 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: 4190003
• MDR Text Key: 5087516
• Report Number: 2936999-2014-00837
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N-560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2009
• 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