MAUDE Adverse Event Report: MMJ SA DE CV (USD) INVOS; OXIMETER, TISSUE SATURATION

Model Number	PMSENS71-A-20
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
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, during procedure, the device showed "signal error detected" and the rso2 values the lower or were not shown.It was indicated that there was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The reported event was not confirmed.The device passed the all test criteria.Unit gave consistent readings with no errors.Inspection of the sensor found no anomalies.The investigation found the device to function normally.No new formal investigation is required, the event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8529804
• Report Number: 2936999-2019-00293
• Device Sequence Number: 1840015
• Product Code: MUD
• UDI-Device Identifier: 20884521556970
• UDI-Public: 20884521556970
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182868
• 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,Followup,Followup
• Report Date (Section B): 12/18/2019

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: PMSENS71-A-20
• Device Catalogue Number: PMSENS71-A-20
• Device Lot Number: AD182501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 10/04/2019; 12/05/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 10/31/2019; 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 82