MAUDE Adverse Event Report: COVIDIEN OXYALERT NIRSENSOR INFANT; CEREBRAL SENSOR

Catalog Number IS-C

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Skin Discoloration (2074); Tissue Damage (2104)

Event Date 06/19/2014

Event Type  Injury  

Event Description

Customer reported: rn noticed small red line under transparent (adhesive surrounding cerebral nirs) on right side.Rn pulled nirs back to investigate and the patient appeared to be in pain.Rn noticed black on the skin and immediately brought charge nurse to bedside.Nirs probe removed and oval shaped dark purple to black wound with square indentation from nirs light was discovered.Physician brought to bedside to assess.Patient evaluated by wound care and plastic surgery for appropriate treatment.Wound was left open to air.Dermagel (elasto-gel) dressing was placed the following day, old bloody drainage on edge of lesion as blister had loosened.Wound is being treated with elastogel dressing every 3-5 days and wound care following patient.

Manufacturer Narrative

(b)(4).Covidien has attempted to gather further details surrounding the circumstances of this report.If additional information is received, a supplement report may be filed.

• Brand Name: OXYALERT NIRSENSOR INFANT
• Type of Device: CEREBRAL SENSOR
• Manufacturer (Section D): COVIDIEN; new mervue industrial; galway ; EI
• Manufacturer (Section G): COVIDIEN; michael collins rd.; new mervue industrial park; galway ; EI
• Manufacturer Contact: denise braxton ; 6135 gunbarrell ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4143397
• MDR Text Key: 4782683
• Report Number: 8020893-2014-01958
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IS-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 8 MO