MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

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, the autopulse platform (sn (b)(4)) powered on but the lifeband would not adjust to patient's chest.The crew attempted to reset 3 times but were unable to fix issue.The crew reverted to manual cpr.No known impact or consequence to patient was reported.

Manufacturer Narrative

The reported complaint of lifeband would not adjust to patient's chest on the autopulse platform serial #(b)(4) was not confirmed during functional testing.However, user advisory - ua07 (discrepancy between load 1 and load 2 too large) was observed in the archive data, thus confirming the reported complaint.The investigation findings revealed that the root cause of the reported issue was due to the patient not oriented on the autopulse platform correctly or the patient has shifted during compression as result of unintended user error.Unrelated to the reported complaint, a cracked front cover of the ap platform was observed during visual inspection.This type of physical damages attributed to user mishandling.The damaged part was replaced.In addition, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The clutch plate was deburred to remedy the fault.During archive data review, multiple ua07 error messages were observed.Thus, confirming the reported complaint.The ap platform passed all functional tests without any fault or error during the initial functional testing.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 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: 8136162
• MDR Text Key: 129473563
• Report Number: 3010617000-2018-01218
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 12/18/2018

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1