MAUDE Adverse Event Report: MEDIANA CO. LTD. NELLCOR; OXIMETER

Model Number	PM1000N
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one unit was returned for evaluation.The report was confirmed during testing.It was found that the switch panel membrane was worn and the battery was older than 2 years.The pmmod, front enclosure, and battery were replaced, and the software was updated, which resolved all the unit¿s issues.Uut (unit under test) was checked for proper operation, current upgrades and revisions.The unit was performing to specification.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device had low oximetry reading.It was reported that the newborn being monitored had 93% to 95% spo2 but when connected to another monitor, it measured 98%.Customer reported that there was no patient harm.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 220-8 01; KR 220-801
• MDR Report Key: 7655846
• Report Number: 2936999-2018-00426
• Device Sequence Number: 125973
• Product Code: DQA
• UDI-Device Identifier: 10884521182493
• UDI-Public: 10884521182493
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PM1000N
• Device Catalogue Number: PM1000N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1