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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform ((b)(4)) displaying a system error message was confirmed during functional testing and archive data review; the root cause was due to a defective processor board.The autopulse platform is a reusable device and was manufactured on 24 jun 2011 it has exceeded its expected service life of 5 years, the device is almost 7 years old.The platform has not seen regular preventive maintenance.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message on the display screen.It was indicated that the processor board was defective.The archive data was reviewed and contained a system error 136 (internal parameter corrupted).As part of routine service during testing, the platform was examined and found physical damage.The observed physical damage is attributed to the normal wear and tear due to the age of the device, it is unrelated to the system error message.Upon customer approval, the processor board and the damaged component will be replaced.The platform will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for the autopulse platform with serial number (b)(4).

Event Description

During a training session, the autopulse platform ((b)(4)) displayed a system error, out of service, revert to manual cpr message.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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7535552
• MDR Text Key: 108996321
• Report Number: 3010617000-2018-00494
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2011
• 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