MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR, PRODUCT CODE: DRM

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for investigation.Visual inspection of the returned platform was performed, front enclosure and battery lock were damaged.The autopulse platform is a reusable device and was manufactured on 08/23/2013.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device and is unrelated to the reported complaint.No issue was noted with the lcd reading and lcd backlight was also confirmed to be functional.The archive review was performed, however full archive data could not be downloaded due to corruption at processor board.In the archive, multiple ua16 (timeout moving to take-up position) were noticed on (b)(6) 2016 which was shown as date when device was power on last.The functional testing was performed and device passed all testing.It was unable to duplicate ua 16, indicating that the ua 16 observed on (b)(6) 2016 was cleared by the customer.In summary customer's reported complaint of ua 16 was confirmed through archive review, however the error was not confirmed through functional testing.The root cause for the reported complaint cannot be determined.The defective processor board, battery lock and front enclosures were replaced.

Event Description

It was reported that the autopulse unit was displaying user advisory(ua)16 (time out moving to take up position), which was not able to be cleared by customer.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR, PRODUCT CODE: DRM
• 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: 5845546
• MDR Text Key: 51113146
• Report Number: 3010617000-2016-00535
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• 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: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• 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: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1