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

Model Number MODEL 100

Device Problems Erratic or Intermittent Display (1182); Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020, the returned autopulse platform (serial # (b)(4)) was service for preventive maintenance (pm).During the functional testing, the autopulse platform displayed user advisory "(ua)41" (patient temperature sensor failure) error message.However, during run-in test for 40 to 60 minutes, ua41 could not be duplicated.Possible root cause could be due to intermittent technical problems in the temperature sensor that may not be directly identified during testing.Also, the lcd screen flickers.The probable root cause for the flickering lcd screen was due to a defective lcd screen as a result of normal wear and tear.The autopulse platform was manufactured in 2014 and is 6 years old, past the expected service life of 5 years.The service repair and final test were not performed because the customer declined the repair quote.No physical damage was observed on the returned autopulse platform during visual inspection.A follow up will be submitted once customer decide to get the device repaired.

Event Description

On (b)(6) 2020, during preventive maintenance (pm), the autopulse platform (serial # (b)(4)) displayed user advisory "(ua) 41" (patient temperature sensor failure) error message during initial functional testing.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10312447
• MDR Text Key: 200201229
• Report Number: 3010617000-2020-00717
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2020

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2014
• 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