MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform displayed an error message user advisory (ua) 02 (compression tracking error) intermittently was confirmed during the load cell characterization test and archive data review.The root cause for the user advisory (ua) 02 error was due to a defective load cell module 2, likely attributed to mishandling such as a drop.During visual inspection, there was no physical damage observed on the autopulse platform.In addition, during the visual inspection, unrelated to the reported issue, found the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.This type of drive shaft issue is the characteristics of normal wear and tear.Deburring of the clutch plate was performed to remedy the encoder driveshaft issue.The autopulse platform is a reusable device and was manufactured in november 2013 and is almost 7 years old, well beyond the expected service life of 5 years.Review of the archive data indicated error message user advisory (ua) 02 around the customer reported event date, thus confirming the reported complaint.Also, the archive shows the presence of user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message as it is related to the defective load cell issue.The load cell characterization test revealed that one of the load cells is defective.The load cell was replaced to address the user advisory (ua) 02 error.Following the repair, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

Event Description

During the patient use, the autopulse platform (b)(4) displayed a user advisory (ua) 02 (compression tracking error) message intermittently.The user tried to troubleshoot by pulling the lifeband up and checking the position of the patient, but the error message could not be cleared.However, the platform resumed the normal operation after the restart.No consequences or impact to patient.During the investigation on (b)(6) 2020, the platform failed the load cell characterization test.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, ca
• MDR Report Key: 10497898
• MDR Text Key: 208942847
• Report Number: 3010617000-2020-00896
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2020

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2013
• 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