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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was reproduced during functional testing of the autopulse platform (sn (b)(4)).The platform was received with no physical damage.Initial functional testing found that the platform was unable to power on.It was indicated that the on/off button is not functioning due to a defective power switch cable.As part of routine service during testing, the device was further examined and found that the brake gap was out of specification.A load characterization check was performed and found that the load cell was defective.After replacement of the power switch cable and the load cell, the brake gap was adjusted to specification.The platform was further functionally tested and passed all final testing criteria without any further issue.Review of the archive data found no issue.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

During routine check, the autopulse platform (sn (b)(4)) was inserted with a good known autopulse li-ion battery but was unable to power on.The platform was further tested using other good known autopulse li-ion batteries; however, the same issue was observed.No patient involvement.

• 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: 7382961
• MDR Text Key: 104043067
• Report Number: 3010617000-2018-00323
• 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
• Type of Report: Initial
• Report Date: 03/29/2018

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• 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