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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Device Inoperable (1663); Device Operational Issue (2914)

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

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) not being able to power on with a newly charged battery was unable to be reproduced during functional evaluation of the platform and could not be confirmed upon review of the retrieved archive data.Review of the archive data retrieved from the autopulse platform (sn (b)(4)) revealed that the platform was not in use on (b)(6) 2017.The events recorded on (b)(6) 2017 contained a "battery lost" message caused by the platform losing connection with the battery and powering off.Following this, the platform was powered back on and displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message that was subsequently cleared by the user.The ua 7 error message was attributed to the patient not properly oriented on the platform and was unrelated to the reported event.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported event.The platform was tested including the load characterization and confirmed that both cell modules are functioning within specification.As part of routine service during testing, the platform was examined and found physical damages including a stiff driveshaft.These observations were unrelated to the reported event.After the damaged parts were replaced and the clutch plate was deburred, the platform was further tested and passed all functional testing criteria and met all required specifications without any observed issue.The autopulse platform is a reusable device and was manufactured on 13 july 2005 and has exceeded its expected service life of 5 years.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 the autopulse platform (sn (b)(4)) using a newly charged autopulse battery did not power on during patient use.Replacing to another battery did not resolve the issue.There was no known patient impact or consequence.No further information was provided.

• 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: 6659173
• MDR Text Key: 78155703
• Report Number: 3010617000-2017-00391
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• 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: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2005
• 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