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

Model Number MODEL 100

Device Problems Device Alarm System (1012); Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

It was reported that during a morning shift check, the autopulse platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message upon power up.Customer also noticed condensation in the lcd window.The platform was power-cycled (powered on and off) multiple times and the battery was replaced; however, the message did not clear.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Customer also reported that the platform was previously taken on a code on (b)(4) 2014.However, no patient information was provided and no issues with the platform was reported.The autopulse platform in complaint was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows no visible or physical damage to the platform.A review of the autopulse archive was performed and the reported complaint of a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) fault was confirmed.The archive data shows that multiple ua 7 faults occurred on the reported event date of (b)(4) 2014.Functional testing was performed and the reported issue of a ua 7 fault was reproduced.Upon power up of the platform, ua 7 fault was displayed on the platform.It was found that one of the load cells was not functioning.The reported issue of condensation in the lcd window was not reproduced.The platform was powered on and off multiple times and no condensation was observed in the lcd window.The lcd display was working properly.Based on the investigation, the part identified for replacement was the load cell.In summary, the reported complaint of a ua 7 fault was confirmed based on the archive review and during functional testing.The fault was found to be due to the defective load cell.The reported complaint of condensation in the lcd window was not confirmed.The lcd display was functioning as intended.Upon replacement of the load cell, the platform 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: 3985860
• MDR Text Key: 21317500
• Report Number: 3010617000-2014-00393
• 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: 07/14/2014

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: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2008
• 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