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 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A supplemental report will be filed when the product is returned and investigation has been completed.

Event Description

During shift check, customer reported that the autopulse platform (serial #: (b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering-up.Error message could not be cleared by the customer.No patient involvement.

Manufacturer Narrative

The reported complaint of "system error, out of service, revert to manual cpr" message on the autopulse platform (serial # (b)(4) was confirmed during functional testing and during archive data review.The investigation findings revealed that the root cause of the reported issue was due to a defective system processor board as a result of aging component.Unrelated to the reported complaint, a damaged load plate cover and a cut loop wire patient's head restraint of the autopulse platform were observed during visual inspection.These types of damages on the autopulse platform likely attributed due to normal wear and tear.The autopulse platform is a reusable device and was manufactured in october 2012.The device has been operating for over 6 years and has exceeded its expected serviceable life of 5 years.The damaged load plate cover and cut loop wire restraint were replaced.During archive data review, system error (latch error 132 - internal watchdog timeout (system error)) was observed on the event date, thus confirming the reported complaint.Initial functional testing could not be performed due to "system error, out of service, revert to manual cpr" error message on the screen panel upon device power on.Thus, confirming the reported complaint.To remedy the system error, the defective system processor board was replaced.During re-evaluated, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The ap platform passed all functional tests and approved for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse with serial number (b)(4).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8200539
• MDR Text Key: 131582035
• Report Number: 3010617000-2018-01261
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1