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

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem Death (1802)

Event Date 11/19/2019

Event Type  Death  

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 female patient (in her 80's), the device displayed a "check pads" message.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.Review of the device activity logs confirmed that when the end user attached defibrillation electrodes, they did not change the "lead view" to "pads" and the device remained in lead ii view.Although this prevented the ecg signal from being viewed on the display, this is not an indication of a device malfunction.The log showed that the device recognized the patient impedance.Therefore, the user would need to switch to the "pads" view to obtain the ecg signal via the electrode pads attached to the patient.Had the user pressed any of the defib related buttons or manually selected the "pads" view, the signal would have displayed on the display.There was no malfunction found with the device and this report has been closed as device used incorrectly by user.Analysis of reports of this type has not identified an increase in trend.

• 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: 9446736
• MDR Text Key: 170125017
• Report Number: 1220908-2019-03795
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00847946019259
• UDI-Public: 00847946019259
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2019

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
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 11/19/2019; 11/19/2019
• Supplement Dates FDA Received: 01/13/2020; 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• 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