MAUDE Adverse Event Report: MITG - KENMEX NELLCOR; OXIMETER

Model Number MAXA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report stating that a maxa pulse oximetry unit caused itching of the left index finger of a patient.There was no harm caused to the patient during this event.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MITG - KENMEX; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer (Section G): MITG - KENMEX; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 7108074
• MDR Text Key: 94502907
• Report Number: 9612030-2017-05255
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXA
• Device Catalogue Number: MAXA
• Device Lot Number: 163230052H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2017
• 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): Other
• Patient Age: 45 YR
• Patient Weight: 52