MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4) stopped compressions and displayed 'system error, out of service, revert to manual cpr' error message" was confirmed based on the archive data review and during functional testing.The root cause of the reported complaint was a defective drivetrain motor, likely due to a defective component.There was no physical damage observed on the returned autopulse platform during the visual inspection.Review of the archive data showed system error user advisory (ua) 139 (unable to hold compression position) error message; thus, confirming the reported complaint.The investigation revealed that the drivetrain motor brake assembly air gap was too wide, measured at 0.012", out of the specification (0.008" ± 0.001"), which caused the ua139 error.The brake gap could not be adjusted and continued to open out of specification.Further investigation found that the two motor shaft dimples had widened/worn out.In addition, the conical tip of the two m3-.5 x 4mm set screws were worn out and would not lock into the drivetrain motor shaft dimple locking well and caused the brake to disengage.The defective drivetrain motor will be replaced to address the ua139 error.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering up the device; thus, confirming the reported complaint.Awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

During patient use, after performing 2 compressions, the autopulse platform (sn: (b)(4) stopped compressions.The ems crew repositioned the patient and re-started the autopulse; however, the platformed stopped functioning again after performing 1 compression and displayed "system error, out of service, revert to manual cpr" error message.Manual cpr was performed to finish the call.No consequences or impact to the patient.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10469071
• MDR Text Key: 209172671
• Report Number: 3010617000-2020-00829
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2020

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: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2018
• 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