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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a daily check, the autopulse resuscitation system would not power on.Customer also reported that when the gray on/off button was pressed, no audible click was observed and the lifeband would not retract when the green start/continue button was pressed.There was no report of any patient involvement.No additional details were provided.

Manufacturer Narrative

Customer reported that this autopulse was used for a resuscitation attempt lasting 3.5 hours, the previous night on (b)(6) 2014.Customer also indicated that the batteries were fully charged and there were no observed damages, to either the batteries or the autopulse.Zoll circulation 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 analysis.External visual inspection of the returned platform revealed no damage.However, internal visual inspection revealed that the platform was contaminated with fluid, causing electrical component damage to the motor controller board.Therefore, the customer's reported complaint of the platform "not powering on" was confirmed.Review of the archive data was performed and it shows that no sessions occurred on the reported event date of (b)(6) 2014.During servicing, the platform was stripped, thoroughly cleaned and rebuilt.Functional testing was performed and the platform passed testing.Based on the investigation, the parts identified for replacement are the motor controller board, load plate cover, battery bay seal, channel seal, tinnerman nut, ui interface, ui window, and the ui seal.In summary, the reported complaint of the platform "not powering on" was confirmed during visual inspection.The fault was found to be due to fluid contamination.Upon rebuilding the platform and replacing all of the damaged parts, the platform passed all testing criteria.

• 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: 3654161
• MDR Text Key: 4316867
• Report Number: 3003793491-2014-00115
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/04/2014

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: 8700-0700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2012
• 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