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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform did not power on.Customer swapped out the li-ion battery but the platform still did not power on.It was also reported that the clips from the base of the platform were missing.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Customer also confirmed that their batteries were rotated and that they were fully charged.The autopulse platform in complaint was returned to zoll on 08/25/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform was performed and found the top cover, motor cover, encoder cover, battery cover and patient restraint bracket to be damaged.The returned platform underwent and passed initial functional testing.The system was turned on/off with no problems and ran for 30 minutes using a large resuscitation test fixture (lrtf) with no anomalies or errors exhibited.A review of the platform's archive was performed and no anomalies were found on the reported event date of (b)(6) 2014.A review of the archive was also performed to assess the customer's battery management practices.Review of the archive shows that the customer is properly maintaining their batteries; however, they are not performing daily checks of the platform as recommended in the autopulse user guide.No parts needed to be replaced to remedy the reported complaints.Additional parts replaced not related to the reported complaints to ensure that the autopulse platform is functioning without issue were: the top cover, motor cover, encoder cover, battery cover and patient restraint bracket.The system underwent and passed all final functional testing.The customer's reported complaint of being unable to turn on the platform was not confirmed, as the platform was able to be turned on using both nimh and li-ion batteries at zoll.The customer's reported complaint of missing clips from the base of the platform could not be confirmed as there are no clips located on the base of the platform.

• 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: 4056835
• MDR Text Key: 4807308
• Report Number: 3010617000-2014-00445
• 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: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• 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: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2004
• 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