MAUDE Adverse Event Report: CELESTICA ELECTRONICS S PTE LTD INVOS; OXIMETER, TISSUE SATURATION

Model Number	PMSENS71-A-5
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Failure to Analyze Signal (1539)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: a4, b5, d3 (mfr name, street 1, mfr city, country code, postal code, lot#), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the sensor had erratic readings.It was reported that the sensor had erratic rso2 readings from below 15 to 50s or no readings.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a "coronary artery bypass warm beating ," the sensor had erratic rso2 readings from below 15 to 50s or no readings.The monitor, preamplifier, and cables were swapped out, but the sensor continued to read erratically.The perfusionist placed the sensor on themselves and got normal somatic readings with no issues.The patient could not be monitored, and there was a delay in changing sensor.The procedure lasted for a few minutes.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a "coronary artery bypass warm beating ," the sensor had erratic rso2 readings from below 15 to 50s or no readings.The monitor, preamplifier, and cables were swapped out, but the sensor continued to read erratically.The perfusionist placed the sensor on themselves and got normal somatic readings with no issues.The patient could not be monitored, and there was a delay in the procedure.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• Manufacturer (Section G): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19121473
• Report Number: 2936999-2024-00630
• Device Sequence Number: 12669809
• Product Code: MUD
• UDI-Device Identifier: 10884521556959
• UDI-Public: 10884521556959
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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-5
• Device Catalogue Number: PMSENS71-A-5
• Device Lot Number: AD230H00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG