MAUDE Adverse Event Report: MITG - GALWAY CEREBRAL/SOMANTIC MONITOR; OXIMETER

Model Number IS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Irritation (2076)

Event Date 01/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the event occurred in nicu, there was a damaged to skin after sensor removal.It was reported that the sensor was not removed in 5 days.The reports stated that the site was assessed daily and site looked normal when nurse noticed sensor irritation and contacted the nnp who advised to leave it open to the air.The customer indicated that there was skin injury to patient at sensor site.Device is discarded by the customer.

• Brand Name: CEREBRAL/SOMANTIC MONITOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MITG - GALWAY; new mervue industrial park; galway
• Manufacturer (Section G): MITG - GALWAY; new mervue industrial park; galway
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 7294401
• MDR Text Key: 100899447
• Report Number: 2936999-2018-00109
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS
• Device Catalogue Number: IS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2018
• 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 Age: 16 DA