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

Model Number MODEL 100

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2015

Event Type  malfunction  

Event Description

It was initially reported that during a shift check, a crack was found near the on/off button of the autopulse platform.No patient involvement 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) 45 (not at "home" position after power-on/restart) message occurred on the reported event date of (b)(6) 2015.Although the customer did not report this, ua 45 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 04/03/2015 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found that the yellow bumper peeled off on the encoder cover and the head restraint brackets were cracked.In addition, visual inspection confirmed the customer's initial complaint that there was a crack near the on/off button of the autopulse platform.The physical damages found during visual inspection are attributed to normal wear and tear (autopulse was manufactured on 11/10/2004).The platform underwent initial functional testing with no faults or errors exhibited.A review of the platform's archive data was performed and found that one user advisory (ua) 45 (not at "home" position after power-on/restart) message occurred on the reported event date of (b)(6) 2015.Ua 45 is most commonly exhibited when the lifeband straps are not fully extended before pressing start.Based on the investigation, the parts identified for replacement were the top cover, encoder cover and head restraint brackets.In summary, the customer's initial reported complaint that there was a crack near the on/off button of the autopulse platform was confirmed through visual inspection.The root cause was determined to be normal wear and tear, given the platform's age.Review of the platform's archive data indicated that a ua 45 message occurred on the reported event date.Per the autopulse resuscitation system model 100 user guide, "the autopulse driveshaft has a "home" position that is a point of reference for autopulse operation.If the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.Based on the evaluation of the platform, there were no mechanical issues noted with the platform that could have caused or contributed to the ua 45.The ua 45 was unrelated to the customer's initial reported complaint.

• 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: 4822675
• MDR Text Key: 21768548
• Report Number: 3010617000-2015-00315
• 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: 03/30/2015

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: 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: 04/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2004
• 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