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 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of user advisory - ua07 (discrepancy between load 1 and load 2 too large) on the autopulse platform (serial # (b)(4)) was confirmed during functional testing and archive data review.The investigation findings revealed that the root cause of the reported ua07 was due to defective load cells which is likely attributed to wear and tear.Unrelated to the reported complaint, a cracked front enclosure, a bent battery lock and two missing load plate screws on the autopulse platform were observed during visual inspection.These types of physical damages and missing parts likely attributed to wear and tear.The damaged front enclosure, bent battery lock and missing screws were replaced.During archive data review, multiple ua07 error messages were observed on the event date.Thus, confirming the reported complaint.Additionally, ua17 (motor on for too long during active operation) was also identified but not related to the reported complaint.The initial functional testing of the autopulse platform could not be performed due to ua07 (discrepancy between load 1 and load 2 too large) displayed upon powering on.Thus, confirming the reported complaint.To remedy ua07, the defective load cells identified during service evaluation were replaced.During re-evaluation, the brake gap was unable to adjust and cleaned.This fault caused ua17 and to remedy this issue, the drivetrain was replaced.The autopulse platform was re-tested 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 previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

The customer reported that during patient use, the autopulse platform (serial # (b)(4)) displayed user advisory - ua07 (discrepancy between load 1 and load 2 too large) error message on the screen panel.Customer reverted to manual cpr.No known impact or consequence to patient information was available.

• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8344155
• MDR Text Key: 136856611
• Report Number: 3010617000-2019-00147
• 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: 02/15/2019

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: 01/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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