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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform ((b)(4)) was returned to zoll (b)(4) for evaluation.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).A visual inspection was performed and no discrepancies were observed.A review of the archive was performed and found user advisories (ua) 7 (discrepancy between load 1 and load 2 too large) was noted on (b)(6) 2016; thus confirming the reported complaint.The platform was functional tested and the autopulse exhibited user advisor (ua)7 (discrepancy between load 1 and load 2 too large) thus confirming the reported complaint.Further investigation indicated that one of the load cells (load cell 2) was defective.The load cell 2 was replaced to remedy the ua7.Following service, the power distribution board (pdb) was replaced per routine service procedure.Load cell characterization testing was performed and confirmed that both load cell modules are functioning within the specification.A run-in testing was performed using the 95% patient test fixture (lrtf) for 10 minutes without exhibiting any of the user advisory or fault.In summary, the customer's reported complaint of the platform exhibiting ua 7 was confirmed during archive review and functional testing.The root cause was attributed to a defective load cell 2.After the load cell 2 was replaced the autopulse platform passed all the testing and meets all required specifications.

Event Description

It was reported that during a shift check , the autopulse platform ((b)(4)) displayed user advisory (ua)7 (discrepancy between load 1 and load 2 too large) and the ua7 will not clear after pulling up the life band all the way.No patient involved with this event.

• 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: 6015999
• MDR Text Key: 56992653
• Report Number: 3010617000-2016-00713
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/10/2016

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2007
• 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