MAUDE Adverse Event Report: MMJ SA DE CV (USD) NELLCOR; OXIMETER

Model Number	DS100A-1
Medical Device Problem Codes	High Readings (2459); Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit was giving high pulse rate readings of 200, however when they used different device the patient's pulse rate was 97.It was also reported the product gave low spo2 readings of 50's.Nevertheless, when tried with another unit the spo2 result was normal.There was no patient harm reported.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8573725
• Report Number: 2936999-2019-00318
• Device Sequence Number: 16599776
• Product Code: DQA
• UDI-Device Identifier: 30884522042714
• UDI-Public: 30884522042714
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

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: DS100A-1
• Device Catalogue Number: DS100A-1
• Device Lot Number: 180570012H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1