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

Model Number MODEL 100

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

It was reported that there was some type of fluid in the autopulse platform's display screen.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/27/2015 for investigation.Investigation results as follows: visual inspection was performed and the reported complaint was confirmed.Liquid was observed inside the front panel membrane.The front panel membrane was removed and the liquid was cleaned with isopropanol to remedy the complaint.The bottom enclosure and battery lock were also observed to have been damaged.The platform was functionally tested with a large resuscitation test fixture for 15 minutes and performed as intended.The device passed functional test requirements.The platform's archive data was reviewed and there were no user advisories observed on the reported event date.Based on the investigation, the part(s) identified for replacement were the bottom enclosure and battery lock.In summary, the reported complaint was confirmed during visual inspection.The front panel membrane was removed and the liquid was cleaned with isopropanol to remedy the complaint.Following service, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION 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: 4588066
• MDR Text Key: 5480581
• Report Number: 3010617000-2015-00153
• 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: 02/12/2015

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2008
• 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