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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Event Description

On march 15th, the ems crew attempted to deploy the autopulse platform (b)(6) on a patient in cardiac arrest.Several attempts were made to attach the lifeband around the patient and press start.The band would tighten around the patient but the platform would not perform compressions, giving a message prompting the crew to fully extend the lifeband and press start again.This was attempted 3 times without success.The crew switched to manual cpr.No additional information was provided.Patient's status information was requested but the customer did not provide a response.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

B5 (describe event or problem) and h6 (adverse event problem) were updated.The reported complaint that the autopulse platform (sn (b)(6)) would not perform compressions, giving a message prompting the crew to fully extend the lifeband and press start again was confirmed during the archive data review and functional testing.When an error message is displayed, the platform will not perform compressions, as intended.Based on the archive data review, the error message observed by the customer is likely to be fault code 16 (timeout moving to take-up position), user advisory (ua) 02 (compression tracking error), and (ua) 18 (max take-up revolutions exceeded) error message.(ua) 02 and (ua) 18 were not reproduced during functional testing and were likely attributed to user error.Fault code 16 was confirmed during functional testing.The root cause for the fault code 16 was due to a motor controller board failure, likely due to a failed component.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.Per the battery hangtag - advisory codes description and action, user advisory 18 is an indication that the autopulse® has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.In this case, revert to manual cpr.Visual inspection was performed and found no physical damage to the returned autopulse platform.The archive data review showed the occurrence of fault code 16, (ua) 02, and (ua) 18 error messages on the event date, thus confirming the reported complaint.During initial functional testing, the platform failed due to the displayed fault code 16, thus, confirming the reported complaint.The motor controller board was replaced to remedy the fault.The (ua) 02 and (ua) 18 observed in the archive could not be reproduced.Following service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse platform with serial number (b)(6).

Event Description

On march 15th, the ems crew attempted to deploy the autopulse platform (sn (b)(6)) on a patient in cardiac arrest.Several attempts were made to attach the lifeband around the patient and press start.The band would tighten around the patient but the platform would not perform compressions, giving a message prompting the crew to fully extend the lifeband and press start again.This was attempted 3 times without success.The crew switched to manual cpr.No impact or consequence to the patient.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLLCIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19093640
• MDR Text Key: 340144909
• Report Number: 3010617000-2024-00306
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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