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

Model Number MODEL 100

Device Problems Crack (1135); Device Displays Incorrect Message (2591)

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

Event Date 05/07/2015

Event Type  malfunction  

Event Description

It was initially reported that the outer cover of the autopulse platform was cracked, on the top side near where the lifeband is placed.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the platform exhibited a "system error".Although the customer did not report this, a "system error" is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed which found that the top cover, front encoder, battery compartment, motor cover and head restraint brackets were all damaged.Initial functional testing was performed and no faults or errors were exhibited.The platform also underwent and passed all final functional testing.However, during final inspection the platform exhibited a "system error".Further inspection determined that the processor board was defective.The processor board was replaced to remedy the "system error".A review of the archive was performed and found no anomalies or errors to have occurred on the initial reported event date of (b)(6) 2015.Based on the investigation results, the parts identified for replacement were the top cover, encoder cover, motor cover, battery compartment, restraint brackets and a processor board.In summary, the customer's reported complaint of the top cover being cracked was confirmed through visual inspection of the platform.The root cause of the damage was determined to be normal wear and tear, as the covers to this platform were last replaced in 2007.Following service, the device passed all testing criteria.

• 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: 4776384
• MDR Text Key: 17212859
• Report Number: 3010617000-2015-00290
• 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: 03/23/2015

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: Service and Testing Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2004
• 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