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

Model Number R SERIES

Device Problem Communication or Transmission Problem (2896)

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

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 treat a patient (age & gender unknown) the device was unable to obtain an ecg signal.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.Please refer to medwatch report 1220908-2014-00464 which is a second device for the same patient.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.The device history log shows several "check pads/poor pad contact" messages, however, the device history log also provides evidence that each time the shock button was pressed the device discharged energy.The associated electrodes were not returned to zoll medical corporation for evaluation as part of this investigation.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• 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: 6380763
• MDR Text Key: 69391445
• Report Number: 1220908-2017-00463
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• 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: 00847946017217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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