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

Model Number MODEL 100

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

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

Event Date 02/21/2015

Event Type  malfunction  

Event Description

It was initially reported that the autopulse platform's case was cracked down by the battery compartment.Customer indicated that the platform was not dropped.No adverse patient sequelae was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that a user advisory (ua) 18 (max take-up revolutions exceeded) message occurred on the reported event date of (b)(6) 2015.Although the customer did not report this, ua 18 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 03/05/2015 for investigation.Investigation results as follows: visual inspection was performed and the initial reported issue of the platform being cracked in the area of the battery compartment could not be confirmed.However, the following damages were observed: the screw on the motor cover was missing, the battery partition at the battery compartment was missing and the front encoder and motor covers were damaged.From the condition of the platform, the damages appear to have been due to wear and tear.The platform was functionally tested for 15 minutes with a test manikin and no issues were observed.The platform performed as intended during functional testing.Unrelated to the initial reported complaint, a user advisory (ua) 18 (max take-up revolutions exceeded) was observed on the reported event date.Based on the platform's archive data, the ua 18 code occurred as a result of no load change detected at the load plate due to no object being placed on the platform.Based on the investigation, the parts identified for replacement were the front encoder cover, motor cover including screws and the missing battery partition.In summary, the initial reported complaint of the platform being cracked in the area of the battery compartment was not verified; however, other damages were observed.The damages observed were attributed to wear and tear.Unrelated to the event, a ua 18 was seen on the reported event date and attributed to no load placed on the platform.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: 4639294
• MDR Text Key: 18294805
• Report Number: 3010617000-2015-00196
• 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: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• 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: 03/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2006
• 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