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

Model Number MODEL 100

Device Problems Break (1069); Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

It was initially reported that the autopulse platform had a broken head restraint holder and that the other side is frayed.No patient involvement was reported.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 27 (encoder fault (>3000 rpm)) message.Although the customer did not report this, ua 27 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: visual inspection was performed and the following damages were observed: the head restraint wire was cut/broken, thus confirming the reported complaint.The battery lock, front enclosure and bottom enclosure were also damaged.Based on the condition of the returned unit, the damages appear to have been due to wear and tear.During functional testing, a user advisory (ua) 27 (encoder fault, > 3000 rpm) was displayed.A defective integrated encoder gearbox was found to be the cause of the ua 27.No other issues were noted during functional testing.A review of the archive was performed and the ua 27 occurring during functional testing was also observed to have occurred on (b)(6) 2014.No other user advisory faults were observed on the reported event date of (b)(6) 2014.Based on the investigation, the parts identified for replacement were the top cover, battery lock, front enclosure, bottom enclosure and integrated encoder gearbox.In summary, the reported complaint of the damaged head restraint was confirmed during visual inspection and was found to be due to normal wear and tear.Functional testing resulted in a ua 27 fault which was also observed in the data archive on (b)(6) 2014.Based on the archive, no other ua faults occurred on the reported event date.Following service, including replacement of the damaged parts and defective integrated encoder gearbox, 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: 3929832
• MDR Text Key: 16085904
• Report Number: 3003793491-2014-00337
• 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: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2008
• 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