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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4)) power off during compression was confirmed in the archive data but was not confirmed during the functional testing.No malfunction was observed during functional testing.The autopulse platform functioned as intended.Upon visual inspection, no physical damage was observed.A review of the archive data revealed the autopulse platform powered off multiple times due to fault code 29 (loss of brake connectivity) and multiple fault code 28 (loss of clutch connectivity) around the customer's reported event date; thus, confirming the reported complaint.There is a possibility that the power distribution board (pdb) may have intermittent technical problem that were not able to directly identify during testing.As a precautionary measure, the pdb will be replaced to address the reported complaint.The autopulse platform passed initial functional testing without any fault or error.The autopulse platform passed the run-in test multiple times using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Unable to replicate the customer reported problem.Waiting for customer's approval for service repair.

Event Description

During patient use, the autopulse platform (serial #(b)(4)) power off during compression.Platform only does power on when the crew removed the autopulse li-ion battery and placed back in.Crew performed manual cpr.Per reporter, the two fully charged batteries used for this call have no issues using on other autopulse platforms.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 11096438
• MDR Text Key: 227070930
• Report Number: 3010617000-2020-01309
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2020

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: 12/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• 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