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

Model Number	22550R
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/16/2019
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 8649694
• Report Number: 1219103-2019-00234
• Device Sequence Number: 2358673
• Product Code: DRO
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Device Lot Number: 900209X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death