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

Model Number MODEL 100

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

Upon powering up the returned autopulse platform during preventive maintenance, system error, out of service, revert to manual cpr error message was displayed.The root cause was due to the defective processor board.Unable to download archive data.The autopulse platform is a reusable device and was manufactured in october 2011 and is 6 years old.It has exceeded its expected service life of 5 years.As part of routine service during testing, the platform was examined and front enclosure was observed damaged.The front enclosure was replaced.Following the service and repair, the autopulse was tested functionally and passed successfully with no issue or faults observed.

Event Description

The autopulse platform (sn (b)(4)) was returned for preventive maintenance.As part of routine service, the device was tested and during initial power-up, displayed system error, out of service, revert to manual cpr" error message.

• 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: 7680265
• MDR Text Key: 113757501
• Report Number: 3010617000-2018-00714
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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