MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the broken handle and the lifeband retention pegs on the bottom cover of the autopulse platform was confirmed during the visual inspection.The front and bottom enclosures were observed cracked.The observed physical damage is likely attributed to mishandling such as a drop.The front enclosure and the bottom enclosure need to be replaced to address the physical damage.Upon visual inspection, observed damaged top cover, which is unrelated to the reported complaint.The probable root cause for the top cover damage is due to user mishandling such as a drop.The top cover needs to be replaced to address the physical damage.In addition, during the visual inspection, unrelated to the reported issue, found the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.This type of drive shaft issue is the characteristics of normal wear and tear.Deburring of the clutch plate was performed to remedy the encoder driveshaft issue.The autopulse platform failed initial functional testing due to user advisory (ua) 45 (not at "home" position after power-on/restart) error message displayed upon powering on, unrelated to the reported complaint.To remedy the user advisory (ua) 45 error message, the driveshaft was rotated back to the home position.The archive showed the presence of the user advisory (ua) 12 (lifeband not detected) error messages, unrelated to the reported complaint.The user advisory (ua) 12 error was cleared by the user.User advisory (ua) 12 is the clearable error message.The user advisory (ua) 12 error message alerts when the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.The lifeband clip detect switch inspection shows that the switch lever was able to close and is in a parallel position.The platform was verified using a standard belt test clip aid, the platform was tested and operated as intended.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

Event Description

During the patient use, the customer observed broken handle and the lifeband retention pegs on the bottom cover of the autopulse platform.The crew switch to the manual cpr for approximately 5-7 minutes.Then the patient was placed on the second autopulse platform to continue the resuscitation process.No consequences or impact to patient.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: 10526157
• MDR Text Key: 206801294
• Report Number: 3010617000-2020-00922
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2020

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: 08/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• 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