MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND INVOS; OXIMETER, TISSUE SATURATION

Model Number SAFB-SM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Inflammation (1932)

Event Type  malfunction  

Event Description

According to the reporter, the sensor was used on a pediatric patient who undergone heart surgery.During procedure, the sensor was placed on the patient.After procedure, it was also used for longer than 24hrs on the same spot.The device had caused skin reaction to the patient.

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): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14830234
• MDR Text Key: 302500165
• Report Number: 8020893-2022-00112
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 20884521105901
• UDI-Public: 20884521105901
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K082327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAFB-SM
• Device Catalogue Number: SAFB-SM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• 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