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

Model Number	IS-C
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Skin Irritation (2076); Swelling (2091)
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 caused blister about the size of a piece of rice.The customer reported that it may be a design issue.
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: 7717769
• Report Number: 2936999-2018-00450
• Device Sequence Number: 16424189
• Product Code: MUD
• UDI-Device Identifier: 20884521211121
• UDI-Public: 20884521211121
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: IS-C
• Device Catalogue Number: IS-C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Other