MAUDE Adverse Event Report: COVIDIEN CADENCE PHYSIO PRECONNECT; ELECTRODE

Model Number 22550PC

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a defibrilator electrode.The customer reports: during an arrest, when the emt pulled open the package, the wires pulled apart.They had to open/use another package.

• Brand Name: CADENCE PHYSIO PRECONNECT
• Type of Device: ELECTRODE
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6028333
• MDR Text Key: 57693724
• Report Number: 1219103-2016-00018
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 22550PC
• Device Catalogue Number: 22550PC
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 10/13/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1