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

Model Number R SERIES

Device Problems Sparking (2595); Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), sparks were seen coming from the attached electrode pads.After removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient sustained burns.The severity of the burns sustained was not available.

Manufacturer Narrative

Zoll medical canada evaluated the device and the device performed to specification.The device was recertified and returned to the customer.The device was passed all testing including bench handling and defib functional stress testing without duplicating any type of malfunction.Review of the device logs showed evidence of poor coupling to the patient.Electrode pads were not returned as part of the investigation.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Patient burns can be associated outcome with defibrillation events and is identified in labeling as an expected risk.Analysis of 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
• MDR Report Key: 10788077
• MDR Text Key: 214651271
• Report Number: 1220908-2020-03611
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other