MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number PROPAQ MD

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that the device inappropriately shut down.When powering the device back on, the device failed self-test for ecg.Complainant did not indicate that there was any patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation; the malfunction of the device shutting down was observed in the device history log.The device was put through extensive testing without duplicating the malfunction.The device's monitor board was replaced as a precaution.The malfunction of the device failing self-test for ecg was duplicated and the device's ecg board was replaced to remedy the condition.Analysis for 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: 5057844
• MDR Text Key: 25496010
• Report Number: 1220908-2015-02222
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/18/2015

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
• Other Device ID Number: 00847946017644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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