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 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message during power on was confirmed during functional testing and archive data review.The root cause of the system error was due to a defective processor board as a result of wear and tear.The autopulse platform was manufactured in september 2007 and is 13 years old, well past beyond its expected serviceable life of 5 years.During visual inspection, crack front and bottom enclosures were observed on the returned autopulse platform.The damaged enclosures are likely attributed to mishandling, such as a drop.The front and bottom enclosures were replaced to remedy the damaged issues.Also observed, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch, likely due to wear and tear.Deburring on the sticky clutch plate was performed to remedy this issue.The damages and faulty clutch on the autopulse were unrelated to the reported complaint.During archive data review, a system error 132 (internal watchdog timeout) was recorded, thus confirming the reported complaint.The initial functional test failed due to returned autopulse platform displayed "system error, out of service, revert to manual cpr" during power on.To remedy the system error, the defective processor board was replaced.Thus, confirming the reported complaint.After service completion, the autopulse 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 autopulse platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

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 on.Customer were unable to clear the error message.No patient involvement.

• 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: 10492768
• MDR Text Key: 206197992
• Report Number: 3010617000-2020-00853
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 09/04/2020

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2007
• 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