MAUDE Adverse Event Report: COVIDIEN GENIUS 2 CHECKER/CALIBRATOR; G2 CALIBRATOR

Model Number 303097

Device Problem Melted (1385)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was found during service that there are 5 pins on the cable and the plastic around the single pin was melted.The g2 cable is not plugged into a power socket, it just connects the g2 thermometer to the calibrator.There was no patient harm reported.There were no wires exposed.There is no live or ground pin, it was just damaged plastic around the pin that looked like it melted.

Manufacturer Narrative

An investigation was performed.After initial review of the information in the complaint file, the complaint was confirmed.The g2 cable that attaches to genius 2 checker/calibrator was found to have a melted pin.A potential root cause for the reported condition is that the unit was connected to a g2 unit that had an issue which caused it to draw excessive current.The damaged g2 cable was replaced to correct the reported issue.The genius 2 checker/calibrator was manufactured in 2010.A review of the device history record shows this device was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Based on the investigation, no corrective action is needed at this time.

• Brand Name: GENIUS 2 CHECKER/CALIBRATOR
• Type of Device: G2 CALIBRATOR
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5500696
• MDR Text Key: 40596673
• Report Number: 3006451981-2016-00146
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 303097
• Device Catalogue Number: 303097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1