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 Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the product for evaluation, however, investigation is pending.A supplemental report will be filed when the investigation has been completed.

Event Description

During patient use, two to three minutes into compressions, the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr".The crew reverted to manual cpr.No known impact or consequence to patient was reported.

Manufacturer Narrative

The reported complaint of "system error, out of service, revert to manual cpr" 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 system error was due to a defective processor board.Unrelated to the reported complaint, a missing battery partition cover on the ap platform was observed during visual inspection.This type of fault on the ap platform can occur due to user mishandling.The missing cover was replaced.The autopulse platform is a reusable device and was manufactured in january 2007.The device has been operating for 11 years and has exceeded its expected serviceable life of 5 years.The archive data indicated system error (latch error 139 - unable to hold compression) was observed during review, thus confirming the reported complaint.The initial functional testing could not be performed due to unclearable error message.Thus, confirming the reported complaint.To remedy the issue, the error log was cleared.The ap platform was tested and failed brake gap check, unrelated to the reported complaint.To remedy the fault, the drivetrain motor was replaced and the sticky clutch plate was deburred.After service repair, the ap platform was retested and passed all functional tests.The autopulse platform is ready for clinical use.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).

• 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: 8121835
• MDR Text Key: 129032856
• Report Number: 3010617000-2018-01199
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1