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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

On 10 november 2020, during preventive maintenance, the autopulse platform (sn (b)(4)) displayed fault code 08 (motor controller fault detected) and fault code 16 (timeout moving to take-up position) error messages and powered off with a fully charged autopulse li-ion battery.The root cause for the observed fault codes were due to a defective drive train motor and the root cause for the power off issue was due to the defective processor board, likely due to wear and tear since the platform was manufactured in 20 november 2010 and is 10 years old, past its expected serviceable life of 5 years.During visual inspection, observed the front enclosure was cracked and load plate cover was torn.The root cause of the physical damage was due to mishandling such as a drop.The front enclosure and the load plate cover needs to be replaced to address the physical damage.Waiting for customer approval for repair.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).

Event Description

During servicing on 10 november 2020, the autopulse platform (sn (b)(4)) displayed fault code 08 (motor controller fault detected) and fault code 16 (timeout moving to take-up position) error messages and powered off with a fully charged autopulse li-ion battery.No patient involvement.

• 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: 10954113
• MDR Text Key: 225799178
• Report Number: 3010617000-2020-01217
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

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: 09/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2010
• 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