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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Patient 3 of 3: the customer reported that during patient use, the autopulse platform (b)(6) repeatedly powered itself off.The platform displayed a prompt to adjust the patient's position, followed by a sound from the device before the platform shut off completely.The autopulse platform would only turn on by removing the battery and reinstalling it.The crew switched to manual cpr.The customer believed the reported issue may have happened 2-3 times.The batteries were tested in other autopulse platforms with no issues.No patient details are available.The patient's status information was requested, but the customer did not provide a response.

Manufacturer Narrative

D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The customer's reported complaint was confirmed based on an analysis of the archive data and functional testing.The customer did not report seeing any user advisory messages or fault codes.However, a review of the archive data revealed that the autopulse platform displayed fault code 16 (timeout moving to take-up position) multiple times on the reported event date.When there is no brake activation, the platform makes clicking noises and powers off shortly afterward, as per system design.Fault code 16 was replicated during functional testing at zoll.The root cause of the issue was a seized brake gap, due to rust, likely resulting from humidity.The review of the autopulse platform archive showed that daily device checks were not performed, and the storage condition of the platform is not known.The customer is in mississippi, which is a high-humidity location.Storing the platform in a less humid place and storing the device wrapped in a soft case (if available) could help prevent the brake gap from seizing.Visual inspection found no physical damage to the returned autopulse platform.Archive data review showed multiple occurrences of fault code 16 (timeout moving to take-up position) on the customer's reported event date.The fault codes were followed by the autopulse platform powering off shortly afterward, confirming the reported complaint.The autopulse platform failed the initial functional test due to fault code 16 displayed during take-up.There was no brake activation; therefore, the platform powered off shortly afterward, confirming the reported complaint.The brake assembly was seized causing the fault code 16 to occur.The brake gap was cleaned using ipa (isopropyl alcohol) to unseized (remove extra metal rust) to remedy the fault.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19000423
• MDR Text Key: 338932065
• Report Number: 3010617000-2024-00273
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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