MAUDE Adverse Event Report: INVOS; OXIMETER, TISSUE SATURATION

Model Number	IS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	11/06/2020
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, there was a wound below the cerebral sensor on a premature patient.The patient was injured.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the sensor had been left on the premature patient for over four days.It was reported that there was a wound below the cerebral sensor on a premature patient.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: use care when placing or removing sensor.Do not place on broken or undeveloped skin.To avoid pressure sores do not apply pressure (e.G.Headbands, wraps, tape) to sensor and periodically check skin integrity according to your institution¿s patient care protocol or at least every 24 hours.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.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• MDR Report Key: 10924746
• Report Number: 2936999-2020-00901
• Device Sequence Number: 11424193
• Product Code: MUD
• UDI-Device Identifier: 10884521211117
• UDI-Public: 10884521211117
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: IS
• Device Catalogue Number: IS
• Device Lot Number: IS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 10/19/2021
• 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: 7 DA
• Patient Weight: 1