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

Model Number	X SERIES
Medical Device Problem Codes	Failure to Charge (1085); Charging Problem (2892)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/23/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device failed to charge, upon another attempt to charge, the device took an extended amount of time to charge to the selected energy.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The reported malfunction was observed during review of the clinical data.However, the reported problem could not be duplicated with the device.The multi-function cable receptacle and the cpr adaptor were replaced as a precaution.The device was recertified and returned to the customer.Review of the device clinical data for this event shows that the device took approximately 12 seconds to charge to 120 joules for the first shock and 15 seconds to charge to 150 joules for the second shock.The data showed that the device took longer than expected but did not exceed the maximum charging time of 25 seconds.The device was able to charge within the time specification and the charges were delivered without delay.There is no record of any other attempts to charge or shock.There were no events recorded to the device activity logs that would indicate that the battery was low or depleted.Additionally, the battery logs do not show any evidence of issues that would contribute to the device charging slowly.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7074684
• Report Number: 1220908-2017-03066
• Device Sequence Number: 939613
• Product Code: MKJ
• UDI-Device Identifier: 00847946012649
• UDI-Public: 00847946012649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death