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

Model Number PMSENS71-A-20

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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
• Type of Device: 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
• MDR Text Key: 142538889
• Report Number: 2936999-2019-00293
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 20884521556970
• UDI-Public: 20884521556970
• Combination Product (y/n): N
• PMA/PMN Number: K182868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 10/04/2019; 12/05/2019
• Supplement Dates FDA Received: 10/31/2019; 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 82