MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number PROPAQ MD

Device Problems Pacing Problem (1439); Failure to Read Input Signal (1581)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during biomed testing, the device would not perform the pacer test and there was no ecg signal via attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing which included power cycling, functional testing, bench handling, pacing and ecg functional testing without duplicating the reported malfunction.The device was recertified and returned to the customer.No trend is associated with reports of this type.Review of the error logs did not find evidence to support the reported event.

• Brand Name: PROPAQ MD DEFIBRILLATOR
• Type of Device: PROPAQ MD
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 8421800
• MDR Text Key: 138828274
• Report Number: 1220908-2019-00793
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00847946020217
• UDI-Public: 00847946020217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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: 03/06/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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