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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

During preventive maintenance, the autopulse platform (sn: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message upon powering on.The root cause for the observed issue was due to a communication error between the drivetrain motor and the processor board, as a result of normal wear and tear.The autopulse platform was manufactured in october 2005 and is almost 15 years old, well beyond the expected service life of 5 years.The platform was connected to the autopulse vision software, and the error message was cleared.There was no physical damage observed on the returned autopulse platform during the visual inspection.The archive data review showed occurrence of system error, user advisory (ua) 136 (internal parameter corrupted) error message.Service will not be performed as the customer declined repair.The autopulse platform will be returned to the customer without the repair, and it will have a label state "not for clinical use".Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

The autopulse platform (sn: (b)(4)) was returned for preventive maintenance (pm).During the functional testing, the autopulse platform displayed "system error, out of service, revert to manual cpr" error message upon powering on.

• 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: 10292982
• MDR Text Key: 199666479
• Report Number: 3010617000-2020-00727
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2005
• 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