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 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform sn (b)(4) shut off was confirmed in the archive review but not during the initial functional testing.The autopulse platform worked as intended.Upon visual inspection, unrelated to the reported complaint, a cracked front enclosure at the front area and the bottom enclosure has multiple cracks in the screw well area were observed, likely due to user mishandling such as a drop.The damaged front and bottom enclosures needs to be replaced to address these physical damages.The autopulse platform passed the initial functional test without any fault or error.A review of the archive data showed under voltage <18v (shutting off unexpectedly) four times during active operation, thus confirming the reported complaint.Nevertheless, the power distribution board (pdb) needs to be replaced as a preventive precautionary measure.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was one similar complaint reported for autopulse platform with serial (b)(4).(b)(6) was reported on (b)(6) 2020, and the pdb was replaced as precautionary measure.

Event Description

During patient use, the autopulse platform sn (b)(4) shut off after 30 minutes of use.The customer replaced the autopulse platform with several autopulse li-ion battries but issue persisted.Another autopulse was used to continue with treatment.Patient's status information was requested but the customer did not provide a response.

• 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: 13215627
• MDR Text Key: 283966972
• Report Number: 3010617000-2022-00028
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• 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: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• 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