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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During patient use, the autopulse platform (sn (b)(4)) stopped compressions and displayed a "system error, out of service, revert to manual cpr" error message.The use of the autopulse platform was discontinued and manual cpr was performed.No consequences or impact to patient.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr" error message" was confirmed during the archive data review but not during the functional testing.The investigation findings revealed that the root cause of the reported system error was due to a damaged drive train motor as a result of wear and tear.The autopulse platform was manufactured in march 2012 and is almost 9 years old, past the expected service life of 5 years.During the visual inspection, a damaged front enclosure was noted.The observed physical damage was unrelated to the reported complaint and likely attributed to user mishandling.The front enclosure needs to be replaced to address the issues.As part of routine service during testing, the platform was examined, and unrelated to the reported complaint, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.The sticky clutch plate was deburred to address the issue.The cause for the sticky clutch could be due to normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.During initial functional testing, the reported "system error, out of service, revert to manual cpr" error message was not confirmed, however, the autopulse platform displayed user advisory (ua) 02 (compression tracking error) and fault code 08 (motor controller fault detected) messages, likely related to the reported complaint.The damaged drive train motor needs to be replaced to address the faults.A load cell characterization check was performed and confirmed that both load cell modules are functioning within the specification.A review of the archive data log showed that during the reported event date, the platform displayed ua 02, fault code 08, ua 17 (max motor on time exceeded during active operation), ua 23 (compression will exceed 3 revolutions), and ua 26 (decompression target not reached) as a definitive sign of the damaged drive train motor, followed by the latch error 71 (motor drive train command issue) system error, thus confirming the customer complaint.The latch error 71 is a software logic related fault as a result of failed communication between the drive train motor and the system processor board.Waiting for customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse platform with serial number (b)(6).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11086053
• MDR Text Key: 227070727
• Report Number: 3010617000-2020-01311
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• 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: 02/06/2021

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1