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

Model Number X SERIES

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: drt, mkj.Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown) the device failed self-test for pacer, defib, and ecg.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical (b)(4) evaluated the device and the reported malfunction was observed but not duplicated.The device was put through extensive testing without duplicating the malfunction.The device's monitor board was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• 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: 5449827
• MDR Text Key: 39102635
• Report Number: 1220908-2016-00355
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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