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

Model Number MODEL 100

Device Problems Crack (1135); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

It was initially reported that on (b)(6) 2015, both head restraints on the autopulse platform were damaged, the housing of the platform was cracked and the load plate screws were missing.No adverse patient sequelae was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the lcd of the autopulse platform was distorted upon power up.Although the customer did not report this, a distorted display is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/19/2015 for investigation.Investigation results as follows: visual inspection was performed and the following was observed: the top cover, battery compartment, bottom enclosure, battery lock pin, front enclosure and battery connector were all damaged.Both shoulder screws were also missing.From the condition of the returned platform, the cause of the damages appear to have been wear and tear.The platform was functionally evaluated with a test manikin for 15 minutes, with no user advisories or warning observed.Unrelated to the initial reported complaint, the lcd was found to be distorted upon power up on (b)(6) 2015.Further inspection identified the cause to be a defective lcd display.A review of the platform's archive data showed no user advisories or warnings on the initial reported event date of (b)(6) 2015.Based on the investigation, the part(s) identified for replacement were the top cover, battery compartment, bottom enclosure, battery lock pin, front enclosure, battery connector, missing shoulder screws and lcd display.In summary, the initial reported complaint of physical damage to the platform and missing screws was confirmed during visual inspection and attributed to wear and tear.Following service, including 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; 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: 4650582
• MDR Text Key: 15320008
• Report Number: 3010617000-2015-00203
• 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: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2007
• 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