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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) not performing continuous compression was not confirmed during functional testing and archive data review.During functional testing the platform was tested using a good known autopulse li-ion battery with a large resuscitation test fixture and operated with continuous compression without error.Data archive review was not able to verify customer complaint; the platform was last used on (b)(6) 2015.As part of routine service during testing, the platform was found to have a hole on the load plate cover and the drive shaft was exhibiting binding and resistance.The load characterization check identified defective load cells.These observations were not related to the reported event.After replacement of the load cells, load plate cover and the deburring the clutch, the platform was functionally tested and operated as intended.The platform passed all testing specifications with no further issue observed.The autopulse platform is a reusable device and was manufactured on 03/13/2008.The platform is 10 years old and has not seen a regular preventive maintenance.Historical complaints were reviewed for service information related to the reported complaint and there was no similar history of related complaints reported for autopulse with serial number (b)(4).

Event Description

During patient use, the autopulse platform ((b)(4)) was not able to perform continuous compression.Following this, the crew immediately performed manual cpr.No user advisory reported.No known impact or consequence to patient reported.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8134130
• MDR Text Key: 129476487
• Report Number: 3010617000-2018-01240
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2018

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: 11/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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