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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

The customer's complaint that the autopulse platform sn (b)(6)stopped working was confirmed during the functional testing and the archive data review.Technical evaluation of the returned device revealed that the autopulse platform stopped working due to fault 08 (motor controller fault detected).The root cause of fault 8 was a seized brake, likely attributed to the rusted/corroded brake assembly area caused by fluid ingress, as mentioned by the customer.Unrelated to the reported complaint, a crack at the front-end area of the front enclosure was noted upon visual inspection.The likely cause of the observed physical damage is user mishandling, such as a drop.The front enclosure was replaced to address the observed physical damage.The archive data indicated fault 08 around the reported event date, confirming the reported complaint.The autopulse platform failed functional testing due to fault 08.Upon internal inspection, zoll observed that the channel die-cast was heavily contaminated by fluid, and a lot of fluid ingress resulted in corroded/damaged top cover metalized coating.The drive train motor has rusted/corrosion at the brake assembly area.The brake body was seized from the rust/corrosion and will prevent the brake from opening or closing during activation.This will cause the autopulse to fail to execute the take-up due to fault 08.Upon using the ipa (isopropyl alcohol) to clean and remove rust/corrosion in the brake housing area.Checked and verified the brake gap was within the specification.The platform was tested with the large resuscitation test fixture (lrtf) without any fault or error.The top cover and the channel die-cast assembly were replaced, and bio-cleaning was performed to address the observed corrosive damage and the contamination caused by fluid ingress.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 no similar complaint was reported for the autopulse platform with sn (b)(6).

Event Description

The customer reported that the hospital staff used the autopulse platform sn (b)(6)after the ems crew transferred the patient care.The hospital staff reported that the autopulse platform stopped working during patient care; however, it is unknown if it was due to the autopulse li-ion battery ran out of power or if there was an issue.When the ems crew received the autopulse platform back from the hospital staff, the crew noted that the platform was covered in blood and was inside the bio-hazard bag.The ems crew has not tested the device due to contamination.No impact on the patient per the hospital staff.

• 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: 18093196
• MDR Text Key: 327642645
• Report Number: 3010617000-2023-00953
• 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: 11/08/2023

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: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• 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