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

Model Number 5100C-EU

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Neurological Deficit/Dysfunction (1982); Injury (2348)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, post-operatively, the patient showed postoperative occurrence of neurocognitive deficits due to generalized ischaemic stroke in right hemisphere and hemiparesis on contralateral side.It was specified that the patient has a past medical history of cerebral deficits in right occipital hemisphere after ischaemic stroke years ago with neurological deficits, was able to move with little disability in left extremities and profound carotid stenosis in right carotid artery with indication for carotid thrombendarterectomy.The customer reported that the monitor worked perfectly as intended in the instructions for use and no issues with technology.The device's reading showed no significant reduction in regional cerebral oxygen saturation.Therefore they decided not to use shunt for bypassing the carotid artery clamps on right side.No alarming desaturations during surgical procedure.Patient woke up after procedure and complains about disability in left side extremities.The patient had injury.

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; michael collins road; galway
• Manufacturer (Section G): MITG - GALWAY; new mervue industrial park; michael collins road; galway
• Manufacturer Contact: avi kluger ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7746963
• MDR Text Key: 115925046
• Report Number: 8020893-2018-00348
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5100C-EU
• Device Catalogue Number: 5100C-EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 70 YR