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 03/11/2017

Event Type  malfunction  

Manufacturer Narrative

The primary complaint of stopped compressions were not confirmed.The customer's reported issue could not be replicated.During visual inspection, the battery latch was found bent.There were no events of stopped compressions recorded on the event date ((b)(6) 2017).However, unrelated to the complaint, multiple user advisory 7 (discrepancy between load 1 and load 2 too large) were noted.Further evaluation found that the platform's load cell 1 and 2 needed to be replace.To avoid the re-occurrence of customer complaint, the platform's powered distribution board was replaced.Additional repair was completed (unrelated to the reported complaint) to ensure that the autopulse platform remains functional without issue.The battery latch and load cell 1 and 2 were replaced.During functional testing, the platform was powered on/off for approximately 10 times.No faults were found.Additionally, while using an lrtf (large resuscitation test fixture, equivalent to 250 pound patient) the platform ran for approximately 20 minutes.The platform passed testing with no faults observed.The autopulse platform is a reusable device and was manufactured in 2010.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

During a code response, it was reported that the autopulse platform (s/n: (b)(4)) would not power on.After the battery was found depleted, a spare battery was used.The platform powered on and provided compressions.While in route to the hospital, it was reported that the platform displayed an unspecified error message to check & realign the lifeband.After adjusting the lifeband, it was then reported that the platform stopped compressions an unspecified time later.No user advisory (ua) messages were observed.Ultimately, the responding team switched to manual cpr.The length of delays troubleshooting the issues were not specified.No further patient information was provided.The platform was later evaluated at the station.According to the reporter, the device powered on with another battery; however, the platform's display appeared distorted and flashing.There were no display issues after the device was restarted.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6447309
• MDR Text Key: 71328917
• Report Number: 3010617000-2017-00250
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• 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: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2010
• 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