MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER ADULT SENSOR PMSENS71-A INVOS KIT; OXIMETER, TISSUE SATURATION

Model Number	PMSENS71-A-20
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2020
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 service and repair, the device caused skin reaction post application of sensors.There was no patient involvement, device was tested with a service and repair personnel.
Additional Manufacturer Narrative
Additional information: g4, 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 which showed a mild reddened rash in the area where the sensor was placed.No open wounds or exudate was present.It was reported that the patient's skin had an issue with the product that was placed in that area.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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: b5, e1(first name, last name, phone number and fax number of initial reporter), e3, e4(email of initial reporter), g3, h6 correction: d3(mfr name, street 1, mfr city, mfr region, country code and postal code) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an in-service demonstration at the hospital by a medtronic representative, the sensor was used and later the representative reported a skin integrity issue after the sensors had been applied.The sensors were discarded after the demonstration.

• Brand Name: ADULT SENSOR PMSENS71-A INVOS KIT
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9859451
• Report Number: 2936999-2020-00214
• Device Sequence Number: 16977241
• Product Code: MUD
• UDI-Device Identifier: 10884521556959
• UDI-Public: 10884521556959
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K182868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 09/11/2020; 04/12/2022
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 09/26/2020; 05/03/2022
• 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 Sex: Unknown