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

Model Number MODEL 100

Device Problem Device Inoperable (1663)

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

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse platform's display did not work.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 in complaint was returned to zoll on 01/08/2015 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found that the battery lock clip was broken and the lcd display background was not functioning properly.During initial functional testing, the system was turned on/off with no problems and ran using a mannequin with no anomalies or errors exhibited.A review of the autopulse platform's archive was performed and found no errors to have occurred on the reported event date of (b)(6) 2014.Based on the investigation, the processor pca was replaced to remedy the customer's reported complaint of the platform's display background not working.The other damaged part noted during visual inspection of the returned platform was also replaced.The platform underwent and passed all final functional testing.In summary, the customer's reported complaint of the platform's display background not working was confirmed through visual inspection of the returned platform.The root cause was determined to be a defective processor pca, which was replaced, remedying the issue and allowing the platform to function 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: 4385445
• MDR Text Key: 5361787
• Report Number: 3010617000-2015-00012
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• 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