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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The customer reported the autopulse platform (sn (b)(6)) failed during a patient call.The platform displayed fault 16 (timeout moving to take-up position).The crew started manual cpr immediately and there was no interruption in care. no additional information is available.Patient's status information was requested but the customer did not provide a response.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6)) displayed fault 16 (timeout moving to take-up position) was confirmed during functional testing and review of the archive data.The brake body was seized from the rust/corrosion, which prevented the brake from opening/closing during activation, resulting in fault 16.The root cause of the seized brake gap is likely attributed to neglect/user handling.A review of the archive data revealed that frequent daily checks were not performed by the customer, and the storage condition of the platform is not known.Frequent daily device checks and storing the autopulse platform in a low humidity location could help prevent the brake gap from seizing.The lack of regular maintenance and high relative humidity could lead to degradation of the mechanical components of the drive train, including brake seizure.During further visual inspection, no other physical damage was observed on the platform.The power distribution board revision was up to date.Based on archive data review, multiple fault 16 were observed near the event date, thus, confirming the reported complaint.The autopulse did not achieve the target depth for take-up within the specified time (~5 secs) due to the drive train motor having rust/corrosion at the brake assembly area.The autopulse platform failed to execute the take-up during initial functional testing due to fault 16, thus, confirming the reported complaint.To remedy the fault code, ipa was used to clean and remove rust/corrosion at the brake housing area.The brake gap inspection was performed and verified the brake gap was within the specification of 0.008" ±0.001".Subsequently, the platform was tested with the large resuscitation test fixture (lrtf) without any fault or error.After 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 was no previous history of complaint reported for autopulse platform with sn (b)(6).

• 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): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18851981
• MDR Text Key: 337447402
• Report Number: 3010617000-2024-00189
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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