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 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform displayed user advisory (ua) 41 (patient temperature sensor failure) error message was confirmed in the archive review and during the initial functional testing.Temperature sensor was replaced to remedy the fault.Visual inspection was performed and found damaged front and bottom enclosures, unrelated to the reported complaint.Front and bottom enclosures were replaced to address the issue.The autopulse platform is a reusable device and was manufactured in mar 2013.It has exceeded its expected service life of 5 years.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device and are unrelated to the reported complaint.During functional testing, the platform displayed (ua) 41 upon powering up, thus confirmed the reported complaint.Review of the archive data show (ua) 41 error messages occurred on the reported event date.After replacing the defective parts, 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.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse with serial number (b)(4).Ccr (b)(4), reported on (b)(6) 2014.Temperature sensor was replaced to address this complaint.

Event Description

During shift check, autopulse platform ((b)(4)) was displaying an error message user advisory (ua) 41 (patient temperature sensor failure).Customer tried to clear the error, however, the issue was not resolved.No patient involvement on this issue.

• 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: 7652994
• MDR Text Key: 112891627
• Report Number: 3010617000-2018-00696
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2013
• 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