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

Model Number MODEL 100

Device Problems No Device Output (1435); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (b)(4) was returned to zoll for investigation on 06/30/2016.Investigation results as follows: device history record (dhr) was reviewed and no previous related complaint was reported for this autopulse platform (b)(4).Visual inspection of the returned platform was performed and hole was noted on the plate cover.The autopulse platform is a reusable device and was manufactured on (b)(6) 2012.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device.The archive was unable to be downloaded.It was no possible to perform functional testing as user advisory (ua) 7(discrepancy between load 1 and load 2 too large) message was observed upon power-up.In summary ua 7 was confirmed as reported by zoll (b)(4) technical service.The device powered on, and the lcd displayed a blank screen.The load cell characterization test confirmed load cell module 2 was defective which caused the ua 7 observed during functional testing.The archive was not downloaded due to defective processor pca board.The clutch plate was noted to be sticky, however issue reported with lifeband retention test was not confirmed.

Event Description

It was reported that the autopulse platform did not have any physical damage.However, the platform could not be powered on and would not communicate with the autopulse vision of the platform processor board.The processor board was replaced an the platform powered on and performed 80 compressions.Additionally, the clutch was sticky and the lifeband retention test failed.There was no patient involved.

• 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: 5800707
• MDR Text Key: 49762798
• Report Number: 3010617000-2016-00504
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2012
• 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