MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2017

Event Type  malfunction  

Manufacturer Narrative

Initial functional evaluation of the returned platform confirmed the reported issue of lcd display blank screen and clicking reset sound when device was powered on.The issue was attributed to a defective processor board.The processor board was replaced to remedy the issue.Once completed, the autopulse passed the final functional testing with no issue or faults observed.Visual inspection was performed and no physical damage was observed.Archive log was not able to download due to the platform unable to perform initialization.The initial functional testing could not be perform due to the device failed the initialization (power on self-test).Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

A (b)(6) male was electrocuted while working on the roof of his house and fell 10 ft to the ground.Patient was unresponsive and there was no sign of life.Manual cpr was started immediately upon arrival.Patient was defibrillated twice and placed on autopulse.According to the incident report, the autopulse performed compressions successfully before transportation and during transportation for unknown period of time.During transport, the autopulse stopped working (the screen went blank and all the error lights went on and made a clicking sound).Manual cpr was performed for unknown length of time through remainder of transport to the emergency room.Rosc (return of spontaneous circulation) was never achieved.The death was not attributed to the autopulse platform by the customer.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6659196
• MDR Text Key: 78150205
• Report Number: 3010617000-2017-00425
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/21/2017

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: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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: 47 YR