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

Model Number MODEL 100

Device Problems Crack (1135); Device Damaged Prior to Use (2284); Device Displays Incorrect Message (2591)

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

Event Date 10/28/2014

Event Type  malfunction  

Event Description

It was initially reported that the when the autopulse platform was removed from the shipping carton, it was noticed that the base covering was cracked at the mounting location of the top handle area.No other issues were reported and 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) 20 (position out of range) and a (ua) 45 (not at "home" position after power-on/restart) message occurred on the reported event date of (b)(6) 2014.Although the customer did not report these, ua 20 and ua 45 are considered reportable malfunctions.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.The customer reported that the cover was cracked upon receipt.Further investigation reveals that the damage appears to have been due to mishandling.A review of the autopulse archive was performed and the archive data shows ua20 (position out of range) and ua45 (not at "home" position after power-on/restart) faults occurred on the reported event date of (b)(6) 2014.However, these faults are not related to the reported complaint.Functional testing was performed and the platform passed testing.Based on the investigation, the part identified for replacement was the front cover.In summary, the reported complaint was confirmed during visual inspection.The fault was found to be due to mishandling.The root cause for ua20 and ua45 faults could not be determined.Upon replacement of the front cover, the platform was re-evaluated through functional testing and the platform passed all testing 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: 4292497
• MDR Text Key: 5272652
• Report Number: 3010617000-2014-00642
• 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: 11/20/2014

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/02/2014
• 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