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

Model Number 22770P

Device Problem Failure to Sense (1559)

Patient Problem No Information (3190)

Event Date 02/06/2020

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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event 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
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): MA028 MA-CHICOPEE; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 15 hampshire st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9801279
• MDR Text Key: 182628777
• Report Number: 1219103-2020-00256
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022387
• UDI-Public: 20884527022387
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22770P
• Device Catalogue Number: 22770P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1