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

Model Number MODEL 100

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the lifeband disengaging and falling off from one of the sides was confirmed during the functional testing.The investigation findings revealed a worn autopulse's channel die-cast as a result of wear and tear.The returned autopulse platform was manufactured in october 2011 ad it is nearly 8 years old, well beyond its expected serviceable life of 5 years.The channel die-cast assembly was replaced to remedy the reported complaint.The autopulse passed the initial functional test without any fault or error.Unrelated to the reported complaint, cracked bottom and front covers on the autopulse platform were observed during visual inspection.Also identified, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.In addition, the encoder drive shaft was observed with extended damage.These types of physical damages and faulty component on the platform was likely attributed to an aging device.The enclosures and the encoder need to be replaced to address the damages.Upon customer approval, the components will be replaced and the device will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial number (b)(4).

Event Description

During the lifeband installation, the user was unable to properly install the lifeband in the autopulse platform (sn (b)(4)).Per report, the lifeband fit was very loose and any movement could disengage one of the sides of the lifeband cover plate from the bottom cover of the platform.No patient involvement.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8951326
• MDR Text Key: 156169526
• Report Number: 3010617000-2019-00740
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• 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: 08/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2011
• 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