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

Model Number MODEL 100

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/27/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a shift check, the autopulse® platform would turn on, however, compressions were unable to be initiated.Complainant also reported that the casing on the side of the autopulse was cracked.There were no reports of any patient involvement.No further details were provided.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: the autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform was performed which shows that the top cover, motor cover, encoder cover, battery cover, flexible patient restraint assembly, restraint pin assembly, and the battery compartment were damaged.The physical damages found during visual inspection confirmed the reported complaint that the casing on the side of the autopulse was cracked.However, it is unrelated to the reported complaint of the autopulse being unable to initiate compressions.The damages appear to have been caused by normal wear and tear (autopulse manufactured in 4/2003).A review of the autopulse archive was performed which shows that a ua45 (not at "home" position after power-on/restart) and ua12 (lifeband not present) faults occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported complaint that the autopulse will turn on but will not initiate compressions was able to be reproduced.A ua45 fault was observed upon power up.The lifeband straps were not pulled completely out prior to turning the device on.The drive shaft was rotated back to the "home" position to remedy the reported complaint.After rotating the shaft back to "home" position, the platform passed functional testing.Based on the investigation, the parts identified for replacement were the top cover, motor cover, encoder cover, battery cover, flexible patient restraint assembly, restraint pin assembly, and the battery compartment.In summary, the reported complaint of the casing being cracked on the side of the autopulse was confirmed during visual inspection.The fault was found to be due to normal wear and tear.The reported complaint of the autopulse turning on, but being unable to start compressions was also confirmed during functional testing and review of the archive.The fault was found to be due to the drive shaft not being at the "home" position, causing the platform to exhibit a ua45 thus preventing the platform from performing compressions.The drive shaft was rotated back to the "home" position to remedy the reported complaint.The ua12 observed in the archive review is unrelated to the reported complaint.The root cause for ua12 fault could not be determined.Per the autopulse maintenance guide (p/n 11653-001), ua12 is an indication that the lifeband is not properly installed.Upon replacement of all parts, 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: 4458177
• MDR Text Key: 5428920
• Report Number: 3010617000-2015-00068
• 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,Followup
• Report Date: 01/08/2015

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 01/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2003
• 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