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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2014

Event Type  malfunction  

Event Description

It was reported that during patient use, the autopulse platform performed one compression, then stopped and displayed a "system error, out of service, revert to manual cpr" message.Customer switched out the battery to a li-ion battery (sn: (b)(4)) and then to a nimh battery (sn: (b)(4)) but the message did not clear.No adverse patient sequelae was reported.No further information was provided.

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.

Manufacturer Narrative

The autopulse platform was returned to zoll on 08/19/2014 for investigation.Investigation results as follows: visual inspection was performed and no damages were observed to the autopulse platform.Upon power on of the platform, a "system error" (error code 132 - internal watchdog timeout) was displayed, thus confirming the reported complaint.Due to the error message, no further testing could be performed.Further inspection of the device identified the cause of the "system error" message to be a defective system processor pca board.A review of the platform's archive data was performed and found no user advisories on the reported event date of (b)(6) 2014.However, a system error code 132, consistent with the reported complaint was observed on 04/02/2014.Based on the investigation, the part(s) identified for replacement was the system processor pca board.In summary, the reported complaint of the platform displaying a "system error" message was confirmed upon functional testing as well as during platform archive review.Based on evaluation of the platform, the "system error" was due to a defective system processor pca board.Following service, including replacement of the system processor pca board, the platform passed all test requirement.

• 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: 3985863
• MDR Text Key: 20860696
• Report Number: 3010617000-2014-00395
• Device Sequence Number: 1
• Product Code: DRM
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 08/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2010
• 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