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

Model Number MODEL 100

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed during initial functional testing of the returned autopulse platform (sn: (b)(4)) but was not confirmed in the archive data.The root cause was due to a loose wire connection to the processor board.The autopulse platform is a reusable device and was manufactured in 2009.Therefore, this type of issue is characteristic of normal wear and tear for the life of the device.The loose wire was reconnected to the processor board.Review of the archive data shows no issue.Initial functional testing was not performed due to no power up the platform.Additional repair and upgrade were completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue and current.The damaged battery lock was replaced, the clutch plate was deburred, and the power distribution board was updated.The platform passed functional testing.Historical complaints were reviewed for service information related to the reported complaint and there was no similar history of complaint reported for autopulse with serial number (b)(4).The platform passed all final testing criteria.

Event Description

As reported, the autopulse platform (sn: (b)(4)) did not power on during a shift check.The customer reported troubleshooting with several good charged batteries; however, the power issue was not resolved.There was no patient involvement.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6788822
• MDR Text Key: 82806922
• Report Number: 3010617000-2017-00573
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2009
• 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