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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was unable to be reproduced during functional testing of the autopulse platform (sn (b)(4)); however, was confirmed through archive data review.The autopulse platform is a reusable device and was manufactured on 06 mar 2011.It has exceeded its expected service life of 5 years and is 7 years old.The events recorded on the reported event date of (b)(6) 2018 indicated that the platform inserted with a fully charged autopulse li-ion battery (four green leds) was used on a regular sized patient likely with a stiff chest.The platform performed 827 continuous compressions and displayed a user advisory ua 17 (max motor on time exceeded) error message.The user restarted the platform and cleared the ua 17 error message.The platform using the same battery (state of charge down to three yellow leds) performed 1821 continuous compressions until a recurrence of the ua 17 error message was observed.Following this, the user normally powered the platform off.Functional testing of the platform found no issue.The platform performed continuous compressions with a large resuscitation test fixture, meeting the manufacturer's specification for device compression depth and compression cycle without any malfunction observed.A load characterization check was performed and confirmed that both load cell modules are functioning within the specification.Per the autopulse hangtag - advisory codes description and action, user advisory 17 is an indication that the platform did not reach its target depths within specification.Based on the analysis of the archive data retrieved from the platform, the issue is likely attributed to the stiffness of the patient's chest, a twisted lifeband, and/or the length of time the platform was used performing continuous compression.During a ua 17 error message, the platform is trying to achieve the 20% compression but did not have enough power to achieve this compression rate within 0.38 seconds.The lifeband was not returned for evaluation.A root cause could not be conclusively determined through this evaluation.As part of routine service during testing, the device was examined and found physical damage and the driveshaft exhibiting binding and resistance.This observation is unrelated to the reported event and is attributed to normal wear and tear due to the age of the device.After replacement of the damaged part, clutch plate deburring was performed.The device was further functionally tested and passed all testing criteria.Historical records were reviewed for service information related to the reported complaint and no previous history of complaint was reported for the autopulse platform with serial number (b)(4).

Event Description

During deployment, the user reported that the autopulse platform (sn (b)(4)) performed compression even before the user has not completed aligning the lifeband.The reporter added that following this, the platform displayed a "realign lifeband" prompt and then stopped compression.Following this, the user immediately performed manual cpr on the patient.After an unspecified time, another crew arrived.The patient was transferred to a second autopulse platform and received continuous compression without further issue reported.No known impact or patient consequence 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7360355
• MDR Text Key: 103184652
• Report Number: 3010617000-2018-00295
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001274
• UDI-Public: 00849111001274
• 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: 03/21/2018

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: 8700-0740-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2011
• 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