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

Model Number MODEL 100

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Not returned to zoll.

Event Description

It was reported that during a shift check the autopulse platform display's backlight was not illuminating the display when powered on.The platform is fully functional and the screen can be seen.There was no patient involved with this event.No further information was prvided.It was reported that during a shift check the autopulse platform display's backlight was not illuminating the display when powered on.The platform is fully functional and the screen can be seen.There was no patient involved with this event.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation.Investigation results as follows: visual inspection of the returned platform was performed and found that the battery lock clip was bent.Note that the autopulse platform is a reusable device and was manufactured on 10/02/2011.Therefore, this type of physical damages found during visual inspection can occur due to normal wear and tear and/or physical abuse.A review of the archive was performed and no discrepancies were observed.During functional testing the autopulse platform was run for 5 minutes using a test manikin with no problem.The platform passed all functional tests.In summary the customer's reported complaint is confirmed.The root cause was attributed to a defective printed circuit assembly (pca) processor board which was replaced to remedy the reported complaint.After replacing the pca board and the battery lock, the platform passed all final functional testing.

• 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: 5345472
• MDR Text Key: 35448926
• Report Number: 3010617000-2016-00013
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• 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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2011
• 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