MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number PROPAQ MD

Device Problem Unable to Obtain Readings (1516)

Patient Problem Chest Pain (1776)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's report was not confirmed or replicated.The device was through extensive testing including ecg testing with known good ecg cables and multi-function cables without duplicating the report.The device was recertified and returned to the customer.No accessories were not returned for evaluation.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PROPAQ MD DEFIBRILLATOR
• Type of Device: PROPAQ MD
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17764506
• MDR Text Key: 323611383
• Report Number: 1220908-2023-03546
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PROPAQ MD
• Device Catalogue Number: PROPAQ MD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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