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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

The primary complaint was confirmed during archive review.The root cause of the issue at the time of the event was due to a low remain capacity battery that was used (in the autopulse platform) to compress a large/stiff patient.Visual inspection was performed and found damage to the top and front cover and a bent battery lock.During archive data review, it revealed that the autopulse lithium ion battery (s/n: (b)(4)) was used on december 19 (the presumed event date).The archive data noted that the battery contained 834 mah (milli amp hours); equivalent to about two green led's.At the time of the event, the platform was used to perform 145 compressions for approximately one minute and fifty seconds on a large difficult to compress patient (max load sum exceeded 329 lbs.).The archive data recorded that the autopulse platform stopped compressing due to multiple user advisory 19 (max applied load exceeded) error messages.The overload circuit trips when load cell force exceeds maximum applied force.Functional testing was performed using a large resuscitation test fixture (lrtf) with good known reference test batteries.No issues/faults occurred.Further evaluation also confirmed that both load cell modules are functioning within the specification.The autopulse platform is a reusable device and was manufactured on 09/14/2007.Device history record (dhr) was 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).The autopulse platform passed all the testing and meets all required specifications.

Event Description

During patient use, it was reported that the autopulse platform (s/n: (b)(4)) provided between 2 to 20 compression, then either stopped or powered off completely.Despite restarting the platform, the issue did not resolve.According to the reporter, following the issue the emergency responding team reverted to manual cpr without incident.Contact at marion county was not available for additional information.No known consequence to the patient 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6251725
• MDR Text Key: 64892000
• Report Number: 3010617000-2017-00037
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2007
• 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