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 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4)) displayed "system error, out of service, revert to manual cpr" error message was confirmed during functional testing and archive date review.The root cause of the error message was due to brake gap out-of-specification (too wide) in which is likely attributed to normal wear and tear.The autopulse platform was manufactured in october 2011 and is nearly 9 years old, past beyond its expected serviceable life of 5 years.Brake gap was adjusted to manufacturing specification to remedy the error message.During visual inspection, heavily frayed patient head restraint were observed on the autopulse platform, likely due to wear and tear.The top cover was replaced to remedy the wire restraints issue, unrelated to the reported complaint.During archive data review, a ua139 (unable to hold compression position (system error)) was observed on the reported event date.Thus, confirming the reported complaint.During initial functional testing, the returned autopulse platform displayed "system error, out of service, revert to manual cpr" error message, thus confirming the reported complaint.The error was found due to the drive train motor brake assembly air gap was too wide, measured at 0.014" out of the specification of (0.008" ± 0.001").Performed the brake gap adjustment and successfully adjusted the brake gap back within the specification of 0.08" ±.001".After service completion, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The autopulse platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

During patient use, customer reported that the autopulse platform (serial #(b)(4)) displayed "system error, out of service, revert to manual cpr " on the screen panel.The crew was unable to clear the advisory and immediately performed two minutes of manual cpr prior to arrival at the hospital.No known impact or consequence to patient information was provided.

• 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: 10423391
• MDR Text Key: 203643040
• Report Number: 3010617000-2020-00794
• 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: 08/18/2020

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: 07/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2011
• 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
• Patient Age: 70 YR
• Patient Weight: 127