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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Noise, Audible (3273)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform for investigation.A follow-up report will be submitted when the investigation has been completed.

Event Description

During the resuscitation of a cardiac arrest patient, the autopulse platform (sn (b)(4)) stopped after performing 10-15 minutes of compressions.The crew performed troubleshooting by replacing the autopulse li-ion battery and resetting the lifeband.However, upon resuming the compressions, the autopulse platform stopped and made a clicking sound.The crew had to reset the lifeband again, and the issue persisted.Immediately, the crew reverted to manual cpr for the rest of the call.No consequences or impacts on the patient.

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (sn (b)(6) stopped after performing 10-15 minutes of compressions," which was confirmed during the functional testing and the archive data review.The root cause of the customer's reported complaint was a corroded/rusty and nonadjustable brake gap of the drive train motor, likely attributed to user maintenance.Reviewing the autopulse platform archive revealed that daily checks were not performed regularly.Daily device checks are required per user manual to help prevent the brake from seizing.The customer reported a complaint that "the autopulse platform made a clicking sound" was not reproduced or verified during the functional testing at zoll.However, the corroded drive train motor brake results in no brake activation, which causes open/clicking sound.Unrelated to the reported complaint, a small hairline crack across the handle of the front enclosure was noted upon visual inspection.The root cause of the observed physical damage was likely attributed to normal wear and tear or user mishandling, such as a drop.The front enclosure was replaced to address the observed physical damage.Upon further inspection, unrelated to the reported complaint, the encoder drive shaft does not rotate smoothly and exhibits binding and resistance.The clutch plate was deburred to remedy the problem.The root cause was the sticky driveshaft clutch area, usually caused by sharp edges from all 12-hex edges of the armature plate or burrs on the clutch rotor's surface.The sticky clutch's impact was not severe enough to make the platform non-functional.The archive data review indicated user advisory (ua) 02 (compression tracking error) and ua17 (max motor on time exceeded during active operation) on and around the reported event date.The corroded/rusty and nonadjustable brake gap of the drive train motor is the cause for the ua02 and ua17 messages, thus, confirming the customer's reported complaint.In addition, unrelated to the reported complaint, the archive data indicated ua07 (discrepancy between load 1 and load 2 too large) messages on and around the reported event date.The ua07 message observed in the archive was not reproduced during the testing at zoll, and no device malfunction that could have caused the autopulse platform to display ua07 was noted.User advisory is a clearable message designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse maintenance guide and autopulse user advisory list, user advisory 07 occurs when the load sensing system has detected a weight/load imbalance between the two load cells.The device does not need to be performing compressions for this to occur; it may happen at any time when the device is powered on.User advisory 07 indicates that the patient/manikin is out of position or the patient/manikin is not properly centered.The recommended actions to take for this type of user advisory are: ensure the patient/manikin is properly aligned (armpits on the yellow line), deploy the shoulder restraint to reduce patient/manikin movement, and press restart to clear the ua.The autopulse platform failed functional testing due to ua17 (max motor on time exceeded during active operation) message.Further inspection of the autopulse platform revealed that the corroded/rusty and nonadjustable brake gap of the drive train motor is the cause for the ua17 and ua02 messages, thus, confirming the customer's reported complaint.The drive train motor was replaced to address the customer's reported complaint.The ua07 message observed in the archive was not reproduced during the functional testing.A load cell characterization test confirmed that both cell modules function within the specification.Following service, the autopulse platform passed the run-in and final tests without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with sn (b)(6).

• 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: 16526942
• MDR Text Key: 311378062
• Report Number: 3010617000-2023-00298
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• 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