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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

It was reported that during use on a cardiac arrest patient, the autopulse platform continued to stop and reset.The customer reported that no error codes were observed on the lcd display.Information regarding patient outcome was not provided, however no adverse patient sequelae was reported.The customer also reported that the wire restraints need to be replaced.No further details were obtained.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and no damages were observed.The platform was functionally tested and the reported complaint could not be duplicated.Unrelated to the reported complaint of the platform stopping and resetting, inspection of the device identified that the load cell amp cabling needed to be replaced.A review of the archive was performed no user advisories were observed on the reported event date.During the process of downloading the archive however, a device self-reset was observed thus duplicating and confirming the reported complaint.A probable cause for the device re-set was determined to be that the processor pca assembly was defective.Based on the investigation, the parts identified for replacement were the load cell amp cabling and the processor pca assembly.In summary, the reported complaint was duplicated and confirmed during the process of downloading the archive data for review and is attributed to the processor pca assembly being defective.Following service, including replacement of the processor pca assembly and load cell amp cabling, the device passed all testing criteria.

• Brand Name: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4760252
• MDR Text Key: 5781637
• Report Number: 3010617000-2015-00261
• Device Sequence Number: 1
• Product Code: DRM
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/15/2015

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2008
• 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