MAUDE Adverse Event Report: COVIDIEN CADENCE PHYSIO QC ADULT RTS; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22550R

Device Problem Firing Problem (4011)

Patient Problem Death (1802)

Event Date 05/16/2019

Event Type  Death  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the defibrillator was placed on the patient and a tracing was noted.The machine was charged to 200, and the customer attempted to deliver unsuccessfully.The customer then charged to 360 and again, there was a failure of delivery.The customer changed out the pads, and charged and delivered without issue.The patient expired during the code event but the customer stated they do not believe this was directly related to the malfunction of the pads or delay in treatment.

• Brand Name: CADENCE PHYSIO QC ADULT RTS
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8649694
• MDR Text Key: 146361349
• Report Number: 1219103-2019-00234
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Device Lot Number: 900209X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death