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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) powering off during patient use occurring on (b)(6) 2018 was not reproduced during functional testing of platform, and could not be confirmed through review of the retrieved archive data.The archive data recorded no session around the reported event date of (b)(6) 2018.There was no device deficiency found during evaluation of the platform to indicate a functional issue.The device was functionally tested using a good known autopulse li-ion battery first with a test mannequin operating for 15 minutes and a large resuscitation test fixture for 34 minutes and operated with compression without error.A lifeband clip detect switch inspection was performed and verified that the switch is within specification.The investigation performed a load characterization check and verified that the load cells are within specification.As part of routine service during testing, the device was examined and found physical damage.This observation is unrelated to the reported event and is attributed to mishandling.After replacement of the damaged part, the platform was further functionally tested and passed full specification.Historical complaints were reviewed for service information related to the reported complaint and no similar complaint was reported for the autopulse platform with serial number (b)(4).

Event Description

The autopulse platform did not function as intended during their trial.The platform powered off during use on a patient.The customer powered the platform back on and resumed mechanical cpr.After one cycle of compression, the platform stalled and stopped compression.The hospital discontinued the use of the platform due to the observed event.In addition, the platform also displayed multiple user advisories during use on a patient.No known impact or consequence to patient.In following up with the customer, the customer stated that this reported issue occurred twice during use on a patient; however, the patient outcome is unknown.This represents the first customer reported issue on the platform.Reference mfr 3010617000-2018-00443 for the second reported issue involving the returned autopulse platform.

• 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: 7497240
• MDR Text Key: 107734290
• Report Number: 3010617000-2018-00491
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• 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: 04/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• 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