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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

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

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During routine testing, the autopulse platform (serial#(b)(4) ) immediately shuts down as soon as the lifeband contacts with the manikin.No patient involvement.

Manufacturer Narrative

The reported complaint of the autopulse platform (serial#(b)(6)) immediately shuts down as soon as the lifeband comes into contact with the manikin was confirmed during funtional testing.The root cause is due to the defective drive train motor, likely attributed to wear and tear.The autopulse platform is a reusable device and was manufactured in february 2008, and is over 13 years old, has exceeded its expected service life of 5 years.During visual inspection, not related to the reported complaint, a cracked front enclosure cover and channel side wall were observed.The observed physical damages were appeared to be the characteristics of user mishandling such as a drop.The damaged front enclosure and channel side wall needs to be replaced to address damaged issues.A review of the event log was performed and no significant discrepancies were observed.The autopulse platform failed initial functional testing due to the platform shut down after it displayed user advisory (ua)24 (timeout moving to "home" position) error message, thus confirming the reported complaint.The ua24 error message was not reported by the customer and was not verified in the archive data files.Also, loud noises coming from the motor was observed.The defective drivetrain motor needs to be replaced to remedy these faults.During further functional testing, it was noted that the encoder driveshaft was stiff and could not rotate smoothly, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate, or due to burrs on the surface of the clutch rotor, likely attributed to wear and tear.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.Waiting on customer's approval for service 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)(6).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11566665
• MDR Text Key: 253477625
• Report Number: 3010617000-2021-00231
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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: 03/23/2021
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1