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

Model Number MODEL 100

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of "unable to retract lifeband "was confirmed during the functional testing.The issue was attributed to the seized brake which cause ua16 (timeout moving to take-up position) error message.To remedy the fault, the brake gap was unseized to remedy the issue.The autopulse passed the final functional testing without any errors.Visual inspection was performed and found no damage upon receipt.Archive review found no issue occurred on the reported event date of (b)(6) 2017.Functional testing was performed and "unable to retract lifeband "and ua16 (timeout moving to take-up position) error message occurred when the autopulse start button was pressed on, thus confirming the reported complaint.The brake gap was unseized to remedy and clear the fault.Additionally, the brake gap was measured and found to be within specification.The autopulse passed all the testing with no issue or faults observed and functions as intended.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

As reported the autopulse lifeband would not retract.According to the customer, there was no error message displayed on the platform.No patient involvement was reported.No further information was provided.Follow up attempts were made to gather more information however were unsuccessful.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6819008
• MDR Text Key: 83748399
• Report Number: 3010617000-2017-00704
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• 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: 08/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2013
• 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