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

Model Number R SERIES

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complainant alleged that while defibrillating a (b)(6) male patient, during an elective cardioversion, the clinicians heard a "popping" sound at the time of defibrillation and discovered a second degree burn on the patient's skin after removing the electrode pads.The clinicians noted a "defib pad short" before the electrodes were removed from the patient's skin.The patient was successfully cardioverted.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The reported malfunction of "popping sound" and "second degree burn", were observed during review of the device activity logs and attributed to poor patient contact.The logs showed a large difference between patient impedance and defib impedance.This suggests a connection issue between the electrode pads and the patient's skin.Poor coupling can trap air between the patient skin and the electrode pads and may be why the user observed a "pop" during the discharge of energy.The electrode pads used were not returned as part of this investigation.Testing on a retained sample lot 0218 found no discrepancies related to this report.The reported malfunction of "defib pad short" was seen in the logs.However, the logs indicate that the device displayed this message well after the shock event.This suggests that the defib pad short message was not seen while on the patient and appears to have occurred after the device summary/event records were printed (most likely into the shorting plug).It is also possible that the electrodes were never removed from device and they were shorted together.The device was recertified and returned to the customer.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
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 7390000
• MDR Text Key: 104100499
• Report Number: 1220908-2018-00842
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946002442
• UDI-Public: 00847946002442
• 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: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2007
• 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
• Treatment: PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE LOT 0218
• Patient Outcome(s): Other
• Patient Age: 76 YR