MAUDE Adverse Event Report: MITG - GALWAY INVOS; OXIMETER, TISSUE SATURATION

Model Number	CNN/SNN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device was burnt.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient suffered a burn ulcer with hemorrhagic blisters.It was indicated that the patient had an infection and needed to be intubated.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The sensor was tested for proper operation for a minimum of 24 hours on ac power and was observed to maintain an rso2 reading of 65 which is within the limits.The sensor tested satisfactorily.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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): MITG - GALWAY; new mervue industrial park; galway
• MDR Report Key: 7591960
• Report Number: 2936999-2018-00384
• Device Sequence Number: 1698974
• Product Code: MUD
• UDI-Device Identifier: 10884521106222
• UDI-Public: 10884521106222
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNN/SNN
• Device Catalogue Number: CNN/SNN
• Device Lot Number: A180109X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/29/2018; 08/29/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/11/2018; 09/18/2018; 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 156