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

Model Number	22770P
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/06/2020
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.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 when the patient in full cardiac arrest arrived via ems to the trauma room, pediatric zoll pads were applied and the rhythm was not showing on the monitor despite good quality compressions ongoing.New pads were applied.It was noted that the 1st set of pads did not have gel.Additional information was received stating that there was a minimum interruption as pads need to be changed.The patient current status is unknown.

• Brand Name: CADENCE ZOLL PEDI RTS
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 9801279
• Report Number: 1219103-2020-00256
• Device Sequence Number: 11513913
• Product Code: DRO
• UDI-Device Identifier: 20884527022387
• UDI-Public: 20884527022387
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 22770P
• Device Catalogue Number: 22770P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/06/2020
• Patient Sequence Number: 1