MAUDE Adverse Event Report: MMJ SA DE CV (USD) INVOS PATIENT MONITORING

Model Number	PMPAMP71
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
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 device had low rso2 reading.Over a period of about 10 minutes there were erratic changes in the values for both, left and right, hemispheres, values dropped to nearly 25% absolute.The procedure was accomplished without problems and no injury for the patient.

• Brand Name: INVOS PATIENT MONITORING
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8616921
• Report Number: 2936999-2019-00350
• Device Sequence Number: 19385991
• Product Code: MUD
• UDI-Device Identifier: 10884521552616
• UDI-Public: 10884521552616
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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: PMPAMP71
• Device Catalogue Number: PMPAMP71
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 90