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

Model Number MODEL 100

Device Problems Device Operational Issue (2914); Device Handling Problem (3265)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation.Investigation results as follows: device history record (dhr) was 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).Visual inspection of the returned platform was performed and found the battery compartment cover was missing and the side bumper damaged.The autopulse platform is a reusable device and was manufactured on 07/19/2004.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device a review of the archive was performed and no discrepancies were observed.During functional testing the autopulse platform passed all testing criteria.In summary the customer's reported complaint is confirmed during visual inspection.The potential root cause was attributed to the damaged battery connector which caused difficulty removing the battery after insertion.Battery connector is built onto the power distribution board.Thus replacing the power distribution board remedied the customer's complaint.After replacing all parts identified during investigation, the platform passed all final testing criteria.

Event Description

It was reported that the autopulse battery got stuck in the battery compartment of the autopulse platform (s/n: (b)(4)) and it was difficult to remove.According to the customer, the issue has occurred with multiple autopulse batteries and the external battery latch on the autopulse platform was functioning properly.No patient consequences were reported.

• 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: 5746966
• MDR Text Key: 48100497
• Report Number: 3010617000-2016-00453
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2004
• 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