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

Model Number MODEL 100

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse platform's shaft was stuck.Customer also reported that the load plate screws were missing.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 06/03/2015 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found the following: the head restraint wires were cut, the battery lock clip was bent, the screws on the load plate and bottom enclosure were missing, the battery connector and front enclosure were damaged.The reported complaint that the load plate screws were missing was confirmed during visual inspection.Upon opening the platform, damage from water ingress was noted.Further investigation could not be performed due to the water ingress.It was also observed that the shaft would not rotate, thus confirming the reported complaint that the shaft was stuck.The platform was unable to undergo initial functional testing as it was unable to power on.A review of the platform's archive data was unable to be performed as the data could not be downloaded since the platform did not power on.In summary, the reported complaints that the shaft was stuck and that the load plate screws were missing were confirmed during visual inspection.Upon opening the platform, damage from water ingress was noted.Further investigation could not be performed due to the water ingress.The root cause of the damaged head restraints may have been due to the user cutting them.The root cause of the stuck shaft could not be determined.

• 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: 4860945
• MDR Text Key: 5850579
• Report Number: 3010617000-2015-00354
• 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: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• 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: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2007
• 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