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

Model Number CNN/SNN

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/27/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device was burnt.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INVOS
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): MITG - GALWAY; new mervue industrial park; galway
• Manufacturer (Section G): MITG - GALWAY; new mervue industrial park; galway
• Manufacturer Contact: avi kluger ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7591960
• MDR Text Key: 110765324
• Report Number: 2936999-2018-00384
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 10884521106222
• UDI-Public: 10884521106222
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K091224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 104 DA
• Patient Weight: 156