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

Model Number MODEL 100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2016

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the display flickering was resolved at the customer's site.However, during functional testing, the screen backlight was not illuminating upon power up.The root cause was attributed to a faulty processor board which was replaced allowing the platform to function as intended.The platform was functionally tested; the screen backlight was not illuminating upon power up; thus confirming the reported complaint.Replacing the processor board remedied the reported complaint.Unrelated to the reported complaint, the clutch plate was also sticky and therefore, was deburred.A run-in testing was performed and the platform passed testing without any fault or error.A visual inspection of the returned autopulse platform was performed and found no physical damage to the platform.A review of the archive was performed and no discrepancies were observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

It was reported that during training, the autopulse platform's display panel was flickering with data in the back ground and the backlight was hardly being seen upon power up.The customer then restarted and retested the platform and the issue was resolved.It was unknown if the same battery was used during the event.It was informed that the platform was placed between the hardwood floor and with the carry bag.No patient involved with this event.No other information available.During investigation, the screen backlight was not illuminated upon power up.This is a reportable malfunction.

• 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: 6210408
• MDR Text Key: 63426554
• Report Number: 3010617000-2016-00956
• 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: 12/28/2016

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: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• 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