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

Model Number MODEL 100

Device Problems Device Alarm System (1012); No Display/Image (1183); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

It was reported that during a training, the control panel of the autopulse platform went blank.Subsequently, the entire device could not function.The device did not display any messages before the control panel went blank.It is unknown what was tried to fix the issue.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Customer reported that the last time that the device was known to function normally was about a month ago from the reported event.It is unknown if a daily shift check was performed on the date of the event.It was reported that the customer follows the autopulse battery management procedure.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.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 2014 for investigation.Investigation results as follows: the reported complaint was confirmed during visual inspection.The lcd display was not functional.Further inspection identified that the cause was the processor pca board, which was not functioning properly.Additional damages observed to the platform included a torn load plate cover.From the condition of the platform, the torn load plate cover was due to wear and tear.Due to the defective processor pca board, a functional evaluation could not be performed and the platform's archive data could not be downloaded for review.Following replacement of the board, the device passed functional testing requirements.Based on the investigation, the part(s) identified for replacement were the load plate cover and processor pca board.In summary, the reported complaint was confirmed during visual inspection and attributed to a defective processor pca board.Following service, including replacement of this board, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3911262
• MDR Text Key: 4585421
• Report Number: 3003793491-2014-00313
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• 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: 08/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2011
• 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