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 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4)) displayed user advisory - "(ua) 02" (compression tracking error) message upon powering on was confirmed during the initial functional test and confirmed in the archive log.The possible root cause could be due to a defective drive train motor found during the autopulse evaluation, likely attributed to mishandling indicated by the rust on the drive train.This type of corrosive damage is indicative of either infrequent daily checks and/or indicative of storing the device in a location with high ambient humidity.Based on the archive, the routine shift check of the platform was not performed every day.No physical damage was observed on the returned autopulse platform during visual inspection.During archive data review, multiple ua2 (compression tracking error) occurred on the reported event date, thus confirming the reported complaint.Also, recorded on the reported event date, multiple fault code 8 (motor controller malfunction), ua17 (motor on for too long during active operation), ua18 (maximum take-up depth exceeded) and ua45 (drive shaft not at home position).As a precautionary measure, the motor controller board was replaced to address the fault code 8 (motor controller malfunction), unrelated to the reported complaint.Note that user advisory error messages are designed into the platform when one of several conditions is detected.User advisory 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.In this case, revert to manual cpr.The autopulse user guide instructs to clear (ua) 45, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.The user advisory will persist until the driveshaft is returned to its home position.These uas are unrelated to the reported complaint.The initial functional testing failed due to the returned autopulse platform displayed "ua17" (max motor on time exceeded) error message upon powering on.The investigation findings revealed rust around the bell end of the drive train.Therefore, the root cause of ua17 error was due to a defective drive train motor, possibly related to the reported ua2 error.To remedy, the defective drive train motor was replace.After service repair, 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.Load cell characterization check passed.The autopulse platform passed all other the functional tests.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 deployment for patient use, customer noticed that the autopulse platform (serial #(b)(4)) displayed user advisory - "(ua) 02" (compression tracking error) message upon powering on.Crew wasn't able to clear error "ua 02" and immediately performed manual cpr.No consequences or impact to 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: 10182353
• MDR Text Key: 197123647
• Report Number: 3010617000-2020-00612
• 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: 06/22/2020

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: 06/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2019
• 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