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

Model Number MODEL 100

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Date 04/29/2014

Event Type  malfunction  

Event Description

It was initially reported that the battery retention clip on the autopulse® was broken and would not secure the batteries in the platform.No other problems were reported.The autopulse platform was subsequently returned to the manufacturer for investigation.Upon review of the archive data, it was observed that a user advisory (ua) 12 (lifeband® not present), 45 (not at "home" position after power-on/restart) and a warning 1-low battery warning message occurred on the reported event date of (b)(6) 2014.The customer did not report these messages.These are considered reportable malfunctions.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection identified the following anomalies: the battery compartment, top cover, motor cover and encoder cover were damaged.From the condition of the returned unit, the cause appears to be wear and tear.Functional testing was performed and the platform met all testing criteria.The following user advisories/warnings occurred on the reported event date of (b)(6) 2014: user advisory 12 message (lifeband not present), user advisory 45 (not at home position after power-on/re-start), and a warning 1 - low battery warning.All three error messages are considered unrelated to the reported complaint of physical damage to the platform.Based on review of archive and evaluation of the platform, the ua 12 appears to have occurred due to the lifeband not being properly installed (i.E., the lifeband clip not being properly seated in the driveshaft).The ua 45 was due to the lifeband straps not pulled completely out prior to turning the device on.The low battery warning was due to a battery being placed in the autopulse platform that was not fully charged.Based on the initial investigation, the part(s) identified for replacement are the following: the battery compartment, top cover, motor cover, and encoder cover.In summary, the reported complaint was confirmed based on visual inspection and found to be due to wear and tear.A ua12 fault, ua 45 fault and warning 1 - low battery warning also were found to have occurred on the reported event date, based on the archive review.These faults are considered unrelated to the initially reported complaint.Following replacement of the damaged parts, including the battery compartment, 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: 3903381
• MDR Text Key: 4678074
• Report Number: 3003793491-2014-00290
• 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: 04/29/2014

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: 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: 05/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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