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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (serial #(b)(4)) does not power on was confirmed during functional testing and visual inspection.The root cause of the reported complaint was due to a damaged battery cable in the battery compartment.The physical damaged appeared to be the characteristics of harsh impact due to user mishandling.Further visual inspection of the returned autopulse platform revealed a cracked front enclosure, unrelated to the reported complaint.The observed physical damage appeared to be the characteristics of harsh impact due to user mishandling.The front enclosure needs to be replaced to address the issues.The data archive shows no discrepancy.During functional testing, the autopulse platform failed to power up, thus confirming the reported complaint.The root cause of the reported complaint was due to a damaged battery cable in the battery compartment.The battery cable needs to be replaced to remedy the reported power issue.Zoll is awaiting on customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history complaint reported for autopulse platform with serial number (b)(4).

Event Description

Customer reported that the autopulse platform (serial # (b)(4)) does not power on and the pins inside the battery compartment are bent.It is unknown where the problem occurred.However, patient use information was requested, but no additional information was provided.

• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13202239
• MDR Text Key: 283687511
• Report Number: 3010617000-2022-00016
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• 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: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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