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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of a damaged head restraint was confirmed during visual inspection and was replaced.However, the reported complaint of a stopped compression was not confirmed or reproduced during these evaluation.The platform passed functional testing with no faults found.Review of the retrieved archive data found no significant discrepancies related to the reported stop compression complaint.Unrelated to the complaint, to ensure the autopulse platform is functional without issue, the bent battery lock clip, damaged enclosures, and missing screws were replaced.The autopulse platform is a reusable device and was manufactured in 2008 and has exceeded its expected service life of 5 years.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial (b)(4).

Event Description

During training the autopulse platform (sn: (b)(4)), was placed on continuous mode.The customer, however, reported the platform stopped compression multiple times for an unspecified reason.Additionally, the platform's head restraint cable was found damaged.There was no patient involvement.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7232829
• MDR Text Key: 98864663
• Report Number: 3010617000-2018-00122
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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: 01/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• 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