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

Model Number MODEL 100

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2014

Event Type  malfunction  

Event Description

It was initially reported that during a shift check, the clutch of the autopulse platform was sticky.No patient involvement was reported.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) 2014.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 06/17/2014 for investigation.Investigation results as follows: visual inspection was performed and found the following damages: the front enclosure, bottom enclosure, and clutch plate were damaged.From the condition of the unit, it appears the damages were due to wear and tear.Functional testing was performed no issues were noted.A review of the archive was performed and revealed that a user advisory (ua) 18 (max take-up revolutions exceeded) fault occurred on the reported event date of (b)(6) 2014.From the data, it appears that the fault occurred due to no patient on the platform while the lifeband was being retracted.This fault is also known to occur when the lifeband is being stored in the ready position.Based on the investigation, the parts identified for replacement were the front enclosure, bottom enclosure, and clutch plate.In summary, the reported complaint of a sticky clutch was confirmed during visual inspection and was found to be due to normal 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, 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: 4006943
• MDR Text Key: 4777607
• Report Number: 3010617000-2014-00428
• 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: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• 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: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2007
• 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