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

Model Number MODEL 100

Device Problems Failure to Sense (1559); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that during a shift check the autopulse platform (b)(4)automatically powered off after being powered on.No patient involved with this event.No further information provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll on 12/01/2015.Investigation results as follows: a visual inspection of the returned autopulse platform was performed and the top, motor, and encoder covers were damaged and tears and hole was observed on the load plate cover.Additionally, one patient restraint pin screws on motor cove were missing.Note autopulse is a reusable device and was manufactured in 2004.Therefore, these types of physical damages can occur due to normal wear and tear and/or physical abuse and are not related to the reported complaint of the platform powering down.A review of the platform archive could not be confirmed because the archive file was corrupted.Functional testing could not be performed as the autopulse platform displayed system error upon power up.Further investigation indicated that the processor board was defective.All parts were replaced based on visual inspection.In addition, the defective processor board was replaced to remedy the system error.In summary, the customer's reported complaint of autopulse immediately powers down without being turned off.The ap platform powered up multiple time with no problem.However, a system error message was observed upon power up which was attributed to a defective print circuit assembly processor board.After replacing all parts identified during investigation, the platform passed all functional testing and performed as intended.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5294074
• MDR Text Key: 33425381
• Report Number: 3010617000-2015-00664
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• 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: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2004
• 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