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

Model Number MODEL 100

Device Problems Sticking (1597); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a demo, the autopulse® platform displayed a user advisory 45 (not at "home" position after power-on/restart) message.The customer cut the lifeband and rotated the drive shaft back to the home position and inserted a new lifeband into the platform.A mannequin was then placed onto the platform, however the issue would not resolve.The lifeband would get stuck when the start/continue button was pressed to begin compressions after the stop/cancel button was pressed to pause compressions.This issue occurred twice.There was no report of any patient involvement.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer evaluation.Visual inspection was performed and no damages were observed.The autopulse lifeband (lot #: 12324) was also returned still attached and jammed in the platform.Functional evaluation was performed and the reported complaint of the platform displaying a user advisory 45 (not at home position after power-on/re-start) was confirmed.Further inspection identified the cause to be due to the clutch plate being damaged.Following replacement of the clutch plate, the platform was re-tested with a large resuscitation test fixture lrtf (equivalent to a 250lb patient) for 15 minutes and no user advisories or other issues were observed.The platform performed as intended following replacement of the clutch plate.The platform archive was reviewed and the reported ua 45 was observed on the reported event date of (b)(6) 2014.Previous inspection of the device attributed the ua 45 to be due to the damaged clutch plate.Additional user advisories observed on the reported event date were the following: ua 2 (compression tracking error), ua 12 (lifeband not present), and ua 18 (max take-up revolutions exceeded).Inspection of the device did not identify any mechanical issues that could have caused or contributed to these advisories.These ua codes can occur as a result of mannequin movement on the platform and/or the lifeband being opened or not properly attached to the platform during compressions.Based on reported information indicating that the customer had cut the 1st lifeband used, removed and replaced the mannequin and installed a 2nd lifeband; the causes of the ua 2, 12 and 18 are more likely movement of the mannequin or improper attachment of the lifeband to the platform during use.Based on the investigation, the part identified for replacement was the damaged clutch plate.In summary, the reported issue of the lifeband becoming jammed in the platform was confirmed during initial visual inspection; the autopulse platform (s/n (b)(4)) was returned with lifeband (lot # 12324) still attached with the straps jammed in the platform.The reported complaint of the platform displaying a ua 45 was confirmed during functional testing as well as archive review and attributed to the clutch plate being damaged.In addition to the reported ua45, additional ua codes seen in the archive occurring on the reported event date were ua 2, 12, and 18.No mechanical issues were identified with the platform which could have caused or contributed to these codes.Reported information provided by the customer indicated the cause of these additional user advisories to be movement of the mannequin or improper attachment of the lifeband to the platform during use.Following service, including replacement of the clutch plate, the platform passed all testing.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4405111
• MDR Text Key: 5367181
• Report Number: 3010617000-2015-00031
• Device Sequence Number: 1
• Product Code: DRM
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• 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: 12/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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