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

Model Number X SERIES

Device Problems Invalid Sensing (2293); Communication or Transmission Problem (2896)

Patient Problem Death (1802)

Event Date 11/02/2013

Event Type  Death  

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 defibrillate a (b)(6) old female patient, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that within tro minutes device showed rhythm and the clinician shocked the patient 5 times.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

This follow up medwatch report is reporting the evaluation of the device.This follow up medwatch report is also correcting information submitted on the initial medwatch report.Zoll medical corporation evaluated the device and the device performed to specification.Review of the device activity logs does show occurrence of the reported malfunction; however this does not indicate a device malfunction.It was determined that the user was not in pads view with no ecg cable attached to the patient.The activity log confirms when all defibrillation related criteria was met, the device was capable of delivering therapy.It is noteworthy to mention the electrode pads used at the time of the reported malfunction were not returned to zoll for evaluation.This claim has been closed as device meets specification.The device was recertified and returned to the customer.No trend is associated with reports of this type.

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) year old female patient, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that within two minutes device showed rhythm and the clinician shocked the patient 5 times.Complainant indicated that the patient subsequently expired.

• Brand Name: X SERIES
• 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: 6122328
• MDR Text Key: 60714341
• Report Number: 1220908-2016-02902
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Other Device ID Number: 00847946005979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 70 YR