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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform displayed an error message user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during archive data review and functional testing.Load cells were found defective and a replacement was required.The report of a user advisory (ua) 12 (lifeband not present) was not confirmed during functional testing.Platform displayed the (ua) 12 error message upon powering on the platform without the lifeband being inserted, which the platform is functioning as intended.Visual inspection was performed and found cracked front enclosure and a bent battery lock, unrelated to the reported complaint.Front enclosure and battery lock were replaced to address the issue.The autopulse platform is a reusable device as well as a serviceable device and was manufactured in 2008.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.The platform has also exceeded its expected service life of 5 years.Following the repair, the platform was further tested for 15 minutes with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient and passed all functional testing criteria and met all required specifications.During functional testing, (ua) 07 error message displayed upon powered on the device, thus confirming the reported complaint.Review of the archive data indicated error messages (ua) 07 on the customer reported event date.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 shift check, the autopulse platform ((b)(4)) was displaying error messages user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) and (ua) 12 (lifeband not present).Customer was unable to clear the errors.No patient involvement was reported.

• Brand Name: AUTOPULSE® RESUSCITATION 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7488993
• MDR Text Key: 107606077
• Report Number: 3010617000-2018-00515
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2008
• 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