MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number R SERIES

Device Problem Failure to Capture (1081)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.

Event Description

Complainant alleged that while attempting to pace a male patient (age unknown), the device failed to capture the patient's heart rhythm.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Review of the activity logs did show evidence consistent with the customers complaint.However, there are many factors outside of device malfunctions that could prevent the device from capturing the patients heart rate such as: patient condition, coupling between pads and patient and artifact.The device was put through extensive testing without duplicating the reported problem condition.It is important to note, the electrode pads and multi-function cable used at the time of the event were not returned for evaluation.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 5671082
• MDR Text Key: 45777524
• Report Number: 1220908-2016-01219
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

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
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Other Device ID Number: 00847946017521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1