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 Insufficient Information (4580)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.

Event Description

The customer reported that the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr" error message.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

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 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 is a reusable device and was manufactured in february 2008 and is more than 12 years old, well beyond the expected service life of 5 years.There was no physical damage observed on the returned autopulse platform during visual inspection.The data in the archive was partially recoverable, however, it revealed latch error 136 - internal parameter corrupted, thus confirming the customer complaint.The defective processor was replaced to remedy the system error.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on.After the processor board was replaced, the platform was further tested and failed with user advisory (ua) 02 (compression tracking error) message, unrelated to the reported complaint.The defective load cell was replaced to remedy the fault.The defective load cell was likely attributed to mishandling such as a drop or a defective component.After the service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged 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 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: 11093766
• MDR Text Key: 227070316
• Report Number: 3010617000-2020-01327
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1