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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of system error, message was confirmed during the archive review and functional testing.The autopulse platform was powered on and displayed the error message.The processor board was replaced to remedy the reported complaint.Following service and unrelated to reported complaint, the repair including replacement of the encoder cover, motor cover, battery partition cover, and the processor board, the platform passed all testing criteria.Visual inspection was performed and found damage on encoder cover, motor cover, and the battery partition cover was missing.The physical damage found during visual inspection are considered unrelated to the reported complaint.From the condition of the platform, this damage relate to normal wear and tear for the life of the device.The autopulse platform is a reusable device and was manufactured on 8/15/2005.The platform is 13 years old, well beyond its service life of 5 years.A review of the archive was performed and showed a latch error.Functional testing was performed and the reported issue of system error, was confirmed.The faults were due to the defective processor board.Historical review of complaints for this related reported complaint and there was no previous history of complaints reported for autopulse platform serial number (b)(4).

Event Description

As reported during shift check, the autopulse platform ((b)(4)) was displaying error message "system error, out of service, revert to manual cpr" when powered on.No patient involvement was reported.

• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7447566
• MDR Text Key: 106307214
• Report Number: 3010617000-2018-00458
• 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 Caregivers
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2005
• 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