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

Model Number MODEL 100

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2015

Event Type  malfunction  

Event Description

It was reported that during a shift check, the rubber on/off button fell into the autopulse platform when the customer went to power the device on.The screen briefly lit up but nothing displayed.No patient involvement was reported.No additional details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll on 07/15/2015 for evaluation.Investigation results as follows: visual inspection of the returned platform was performed and found that the power button was missing and the power bracket was broken, thus confirming the customer's reported complaint of the on/off button falling off.The top cover, front enclosure, bottom enclosure and battery compartment were cracked, possibly as a result of being dropped.In addition, it was observed that the autopulse lifeband was falling off because it was unable to lock in place.The channel roller assembly was found to be at fault.A review of the platform's archive was performed and no user advisories or warnings were observed on the reported event date of (b)(6) 2015.The platform was functionally tested, however the customer's reported complaint was unable to be reproduced.The lcd screen was observed to be working properly and the autopulse platform was able to power on/off without any problems.The platform passed all final testing.Based on the investigation, the parts identified for replacement were the top cover, front enclosure, bottom enclosure, battery compartment and the channel roller assembly.In summary the customer's reported complaint that the on/off button was missing was confirmed through visual inspection.The customer's reported complaint of the lcd display not working properly was not confirmed as the display functioned properly during testing.The additional physical damages found during visual inspection are unrelated to the reported complaint.The platform is a reusable device and therefore, these types of physical damages can occur due to normal wear and tear and/or physical abuse.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

• 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: 4954611
• MDR Text Key: 6258049
• Report Number: 3010617000-2015-00429
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/06/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2012
• 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