MAUDE Adverse Event Report: MEDIANA NELLCOR; PORTABLE SPO2 PATIENT MON SYS X1

Model Number PM10N

Device Problem Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was requested to be returned.

Event Description

The customer reported that the patient sat would not come above 93% while at rest.The pm10n portable oximeter monitor was reading 89% on room air as compared to 93% on the n-65 pulse oximeter monitor.No patient harm reported.

• Brand Name: NELLCOR
• Type of Device: PORTABLE SPO2 PATIENT MON SYS X1
• Manufacturer (Section D): MEDIANA; wonju industry park; dongwha-ri,munmak-eup wonju-si; gangwon-do ; KS
• Manufacturer (Section G): MEDIANA; TH
• Manufacturer Contact: ray maroofian ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6349321
• MDR Text Key: 68277262
• Report Number: 2936999-2017-00115
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM10N
• Device Catalogue Number: PM10N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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): Other
• Patient Age: 56 YR