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

Model Number MODEL 100

Device Problems Break (1069); Component Missing (2306)

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

Event Date 05/05/2014

Event Type  malfunction  

Event Description

It was initially reported that during a morning check on (b)(6) 2014, the shoulder ties of the autopulse platform were broken and the tie wires were missing.Customer reported that the platform worked fine.No patient involvement was reported.The autopulse platform was subsequently returned to zoll for investigation.During investigation of the returned platform, it was found that the lifeband clip did not lock into the driveshaft.Although the customer did not report this, unable to install the lifeband is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: visual inspection was performed and the head restraint wire, front enclosure and bottom enclosure were found to be damaged.Visual inspection also confirmed that the lifeband clip did not lock into the driveshaft.Further inspection determined that a damaged integrated encoder gearbox was the cause of this issue.Based on visual inspection results, the reported complaint of the shoulder restraint wires being broken was confirmed.From the condition of the returned platform, the damages appear to have been due to wear and tear.The platform passed all functional test requirements.A review of the archive was performed and there were no user advisory messages on the initial reported event date of (b)(6) 2014.Based on the investigation, the parts identified for replacement were the top cover, damaged encoder gear box, front and bottom enclosures.In summary, the reported complaint was confirmed and found to be due to wear and tear over time.Following replacement of the damaged parts, the device passed all testing criteria.

• 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: 3900757
• MDR Text Key: 4542567
• Report Number: 3003793491-2014-00299
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2008
• 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