MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number PROPAQ MD

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Complainant alleged that while transporting a pt, the device's display blanked out.Complainant indicated that there was no pt involvement in the reported malfunction.

Manufacturer Narrative

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

• Brand Name: PROPAQ MD DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 3843221
• MDR Text Key: 4615697
• Report Number: 1220908-2014-00671
• Device Sequence Number: 1
• Product Code: LDD
• 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
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROPAQ MD
• Device Catalogue Number: PROPAQ MD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• 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