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

Model Number MODEL 100

Device Problems Poor Quality Image (1408); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

It was reported that during a training session, the autopulse platform would stop functioning and the lcd backlight was not working.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Investigation results are as follows: visual inspection of the returned platform was performed, which found that the load plate cover that affects the sealing had holes in it.Functional evaluation of the platform was performed and the customer's reported complaint of the backlight not working was not confirmed.The customer's reported complaint that the platform would intermittently stop was also not confirmed.Run-in testing with a 95 % patient test fixture was conducted for several hours and no faults or user advisories were observed.The autopulse platform passed all testing criteria.A review of the platform's archive was also performed and it was observed that no user advisory or warnings occurred on the reported event date of (b)(6) 2015.The last recorded date of customer usage was (b)(6) 2015.Based on the investigation, the part identified for replacement was the load plate cover.In summary, the customer's reported complaint was not confirmed.Review of the platform's archive data did not find any issues related to the reported complaint.In addition the reported complaint was not duplicated through functional testing.There were no device deficiencies found during evaluation of the platform that could have caused or contributed to the reported complaint.Therefore, a root cause could not be determined.After replacement of part identified during investigation, the platform passed all final functional testing criteria.

• 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: 4863964
• MDR Text Key: 5844967
• Report Number: 3010617000-2015-00360
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2005
• 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