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

Model Number 22661R

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11988044
• MDR Text Key: 255979282
• Report Number: 1219103-2021-00327
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022370
• UDI-Public: 20884527022370
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22661R
• Device Catalogue Number: 22661R
• Device Lot Number: Y12232004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1