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 06/15/2020

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" message was confirmed during functional testing and archive date review.The investigation findings revealed drive train motor brake assembly air gap was too wide, out of specification.The root cause for the occurred system error was due to the defective drive train motor, likely due to normal wear and tear of the platform.The autopulse platform was manufactured in december 2009 and is over 10 years old, past the expected service life of 5 years.During visual inspection, no physical damage was observed but some of the screws are missing from the platform's cover, likely due to wear and tear.Screws were replaced to address this issue.Also, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance as a result of a sticky clutch, likely due to normal wear and tear.Deburring of the clutch plate was performed to remedy this issue.The observed issues were unrelated to the reported complaint.During archive data review, a system error latch139 (unable to hold compression position (system error)) was observed on the reported event date.Thus, confirming the reported complaint.During the initial functional testing, the returned autopulse platform displayed "system error, out of service, revert to manual cpr" error message, thus confirming the reported complaint.The drive train motor brake assembly air gap was too wide (measured at 0.015") and was out of the specification (0.008" ± 0.001").The brake gap could not be adjusted and continues to open out of specification.The conical tip of the two m3-.5 x 4mm set screws have worn-out and would not lock into the drive train motor shaft dimple locking well and caused the brake to disengage.The drive train motor was replaced to address the error issue.After parts replacements, 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 were no similar complaints 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" error message upon powering on.It is not known if troubleshooting was performed by the customer to clear the error.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: 10255600
• MDR Text Key: 198781401
• Report Number: 3010617000-2020-00660
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2009
• 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