MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number PROPAQ MD

Device Problem Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

Event Type  malfunction  

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 attempting to transcutaneously pace a (b)(6) year old male patient, the device failed to capture the patient's heart rhythm.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, ecg and pacer testing using known good cables without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs shows immediately significant amounts of noise through the leads.A clean usable signal is never obtained.There are no error messages seen in the log that would indicate the issues experienced by the user was due to a device malfunction.The ecg cable and electrode pads were not returned as part of this investigation.Without the ecg cable and electrode pads we are unable to confirm the root cause of the customer's report.No trend is associated with reports of this type.

• 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: 7837197
• MDR Text Key: 118899066
• Report Number: 1220908-2018-02510
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 00847946017644
• UDI-Public: 00847946017644
• 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: 08/10/2018

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: 08/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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 Age: 67 YR