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

Model Number MODEL 100

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

It was also reported that a zoll sales representative was able to duplicate the reported problem, as the autopulse was unable to perform take-up.The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation on 7/27/2015 for investigation.Please note that the autopulse lifeband (lot # 56163) and autopulse li-ion battery (s/n (b)(4)) were also returned, however there were no observed issues with these accessories.Investigation results are as follows: visual inspection of the platform was performed and no damage was observed.The customer's reported complaint was duplicated during functional evaluation of the returned platform.Further investigation determined that the processor board was defective.After the processor board was replaced, the platform passed final functional testing.A review of the archive data was attempted however the archive data files were found to be corrupted and unable to be saved as a result of the processor board being defective.Therefore, no data could be retrieved.Based on the investigation, the part identified for replacement was the defective processor board.In summary, the customer's reported complaint that the autopulse was unable to function properly and perform take-up was confirmed during functional testing.Further inspection identified that the processor board was defective.After replacement of the part identified during investigation, the platform successfully passed all final functional testing.

Event Description

It was reported that when the autopulse platform was powered on, a red alert led was exhibited and an audible clicking noise was heard.The platform was also unable to function properly.There was no report of any patient involvement.No further information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4987801
• MDR Text Key: 23847452
• Report Number: 3010617000-2015-00442
• Device Sequence Number: 1
• Product Code: DRM
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• 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: 07/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2007
• 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