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

Model Number MODEL 100

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

During visual inspection, a cracked encoder cover was observed near the top handle and the power distribution board was noted to be an older version.The autopulse platform is a reusable device.The autopulse platform was manufactured in 2007 and is 11 years old, well beyond the expected service life of five years; therefore, this type of damage is characteristic of normal wear and tear for the life of the device.No discrepancies were noted on the archive.During functional testing, a load cell characterization was performed and load cell module 2 was found defective.In summary, the encoder cover, grip strips, load cell and power distribution board were replaced.The platform was further tested and has passed all the final functional testing.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaints for autopulse sn (b)(4).

Event Description

During preventive maintenance of the autopulse platform (sn:(b)(4)), damaged load cell module was observed.No patient was 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7304937
• MDR Text Key: 101511192
• Report Number: 3010617000-2018-00272
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/28/2018

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: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2007
• 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