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

Model Number MODEL 100

Device Problems Loose or Intermittent Connection (1371); Torn Material (3024)

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

Event Date 04/16/2015

Event Type  malfunction  

Event Description

It was initially reported that on (b)(6) 2015, the head restraints on the autopulse platform were damaged, the load sensor cover was torn and the load plate screws were loose.No adverse patient sequelae was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the lcd of the autopulse platform was flickering.Although the customer did not report this, a flickering display is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n 21301) was returned to the manufacturer for evaluation.Visual inspection was performed and the following damages were observed: the head restraint wires were cut, the load plate cover was damaged, the plate screws were loose and the battery lock had broken off of the platform.From the condition of the returned platform, the damages appear to have been due to wear and tear.During functional testing, it was observed that the lcd display was flickering and one of the load cell modules was not functioning properly.Following replacement of the load cell module and lcd display, functional testing was performed and the platform performed as intended.A review of the archive was performed and there were no user advisory codes or warnings observed on the reported event date.Based on the investigation, the parts identified for replacement were the top cover including head restraint wires, the load plate cover, the battery lock, the lcd display and the single point load cell module.In summary, the reported complaint was confirmed during visual inspection and attributed to wear and tear.Following service, including replacement of the damaged parts, the device passed all test 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: 4728957
• MDR Text Key: 5665533
• Report Number: 3010617000-2015-00266
• 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: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2007
• 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