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

Model Number MODEL 100

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Event Description

It was initially reported that the autopulse platform starts up only 50% of the time after pausing the unit.Manufacturer obtained additional information on (b)(6) 2014 which indicated that the autopulse platform was used on a (b)(6) male patient, weighing approximately (b)(6) pounds.Patient was positioned correctly on the platform.However, the platform did not begin any compressions.It only went through a few cycles and then stopped.Customer attempted to restart the platform by pressing the on/off button but was unsuccessful.No adverse patient sequelae was reported.Please note that customer did not provide the date of event.No further information was provided.Manufacturer has requested additional information from the customer; however, no additional information has been obtained.

Manufacturer Narrative

Customer reported that the autopulse would work as designed on a mannequin, but not on real patients.Product in complaint was returned to zoll on 01/13/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

Investigation results as follows: it was determined through review of the autopulse platform's archives, that although the customer could not provide an event date, the event associated with the customer's reported complaint occurred on (b)(6) 2013.Visual inspection of the returned platform found the front enclosure to be cracked and the battery lock to be bent.Evaluation of the platform found no anomalies and was unable to reproduce the customer's reported complaint using zoll testing batteries.Additional review of the platform's archives does confirm the customer's reported complaint of the platform not restarting after pausing.The customer experienced multiple user advisories (ua's) on (b)(6) 2013 while using nimh battery s/n (b)(4).The archive shows that this battery remained in the autopulse from (b)(6) 2013 until (b)(6) 2013 without being charged.At the beginning of the event on (b)(6) 2013, this battery was not fully charged based upon its rc (1196w) and voltage (33v).The customer experienced ua 19 (max applied load exceeded), ua 44 (battery voltage too low during compression (replace battery)), and ua 13 (battery fault detected (replace battery)).Ua 13 will always occur when a battery has exhibited ua 44 and is used without being charged.Further review of the archives determined that this battery had not been properly maintained by the customer.On (b)(6) 2013, this battery showed only 7 charge cycles, which based upon the battery's manufacture date of 03/2012, this battery should have 19 (+/-1) charge cycles.Additional work completed not related to the reported complaint to ensure that the autopulse platform is functioning without issue include replacement of the front enclosure, battery lock and power distribution board (pdb).In conclusion, the customer's reported complaint of the platform not restarting after being paused was confirmed through review of the autopulse platform's archives.The customer experienced multiple ua's (which did not allow compressions to be performed) directly related to the low voltage battery being used at the time.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3591949
• MDR Text Key: 15175665
• Report Number: 3003793491-2014-00043
• 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,Followup
• Report Date: 12/31/2013

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 01/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 70 YR
• Patient Weight: 118