MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number PROPAQ MD

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that during biomed testing, the device failed self-test for pacer function.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to a zoll certified service provider for evaluation.The processor/bridge/pace board was replaced to resolve the malfunction.The device was recertified and returned to the customer.The processor/bridge/pace board was returned to zoll medical corporation, (b)(4) and the customer's report was duplicated and attributed to a faulty inductor on the processor/bridge/pace board.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: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 9457520
• MDR Text Key: 170450044
• Report Number: 1220908-2019-03813
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 00847946017705
• UDI-Public: 00847946017705
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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