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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr" error message" was confirmed during the functional testing and based on the archive data review.The root cause for the system error was due to the defective processor board, as a result of normal wear and tear of the platform.The autopulse platform was manufactured in september 2012 and is 8 years old, well beyond the expected service life of 5 years.Unrelated to the reported complaint, a damaged front enclosure was observed during visual inspection.The front enclosure was replaced to address the issue.This type of physical damage found during visual inspection is characteristic of user mishandling.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering on.The archive data review showed the occurrence of system error - user advisory (ua) 132 (internal watchdog timeout) on the reported complaint date.The processor board was replaced to address the user advisory (ua) 132 system error.Following the service repair, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with sn (b)(4).

Event Description

During the shift check, the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr ".The customer checked all batteries to make sure they are fully charged, however, the error persists.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
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192955
• MDR Report Key: 10480986
• MDR Text Key: 207742465
• Report Number: 3010617000-2020-00851
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2012
• 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