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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll on (b)(6) 2015.Investigation results as follows: visual inspection of the returned platform found no visible damage to the device.A review of the archive showed multiple user advisor 7 (discrepancy between load 1 and load 2 too large) errors on (b)(6) 2015 thus confirming the reported complaint.Functional testing was not performed due to the ua 7 upon power up.Based on the investigation, load cell 2 was replaced to remedy the ua 7.The observed sticky clutch plate was deburred, which resolved the issue.In summary the customer's reported complaint that the platform prompted ua 7 was confirmed during archive review, as well as in functional testing, when the platform displayed ua 7 upon power up.The root cause for the ua 7 was a defective load cell.The user advisories are designed into the autopulse platform.Ua 7 alerts the user that a misalignment or inappropriate movement of the patient or the lifeband has occurred.This condition is typically correctable by the operator.The platform passed all initial and final functional testing criteria.

Event Description

It was reported that during patient use, the autopulse platform s/n (b)(4) displayed user advisory 7 (discrepancy between load 1 and load 2 too large).They were unable to clear the error code.They reverted to manual cpr.No additional patient information was disclosed.No further information on the was provided.

• 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: 5322793
• MDR Text Key: 34267532
• Report Number: 3010617000-2015-00692
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 12/01/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/23/2015
• 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
• Treatment: MANUAL CPR