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

Model Number	22661R
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that they had an incident where a defib patch was not sticking to the patient during the procedure.The customer stated that the ep team was rolling the patient back on his bed when they noticed that the r2 patch was not stuck to the patient.The patient was free of hair and moisture.Additional information received on 4-jun-2021 stated that the procedure being performed was a ep ablation and cardiac cath.The pads had been placed in case for the procedure, they did not need to shock the patient.The procedure was over when the issue was discovered.There was no delay in treatment and no injury occurred.

• Brand Name: CADENCE PHILIPS ADULT RTS
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11988044
• Report Number: 1219103-2021-00327
• Device Sequence Number: 14309301
• Product Code: DRO
• UDI-Device Identifier: 20884527022370
• UDI-Public: 20884527022370
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/11/2021

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
• Operator of Device: No Information
• Device Model Number: 22661R
• Device Catalogue Number: 22661R
• Device Lot Number: Y12232004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/11/2021
• Patient Sequence Number: 1