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

Model Number MODEL 100

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a shift check, it was observed that the lcd backlight on the control panel of the autopulse® platform did not turn on.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Please note that the platform in complaint was returned to zoll (b)(4).Zoll (b)(4) confirmed the customer's reported complaint.Investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) for analysis.Visual inspection of the returned platform shows that the lcd backlight was non-functional.The physical damage found during visual inspection confirmed the reported event.It was found that the lcd was defective.The damage appears to have been caused by normal wear and tear (autopulse manufactured in 3/2012).Functional testing was performed and the platform passed testing.Based on the investigation, the part identified for replacement was the lcd.In summary, the reported complaint was confirmed during visual inspection.The fault was found to be due to the defective lcd.Upon replacement of the lcd, the platform was re-evaluated through functional testing and 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: 3962228
• MDR Text Key: 4609018
• Report Number: 3003793491-2014-00378
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/02/2014

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2012
• 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