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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint of autopulse displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was confirmed in the archive review, but not during the initial functional testing.The driveshaft was rotated back to home position prior to the platform evaluation.The likely root cause of the reported (ua) 45 error message was due to user error.Per the autopulse user guide instruction, 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.Visual inspection of the returned platform was performed and found no physical damage.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, the sticky clutch was noted.The sticky clutch plate was deburred to address the issue.The autopulse platform is a reusable device and was manufactured in april 2011, and is 7 years old, well beyond the expected service life of five years.Therefore, this type of issue is characteristic of normal wear and tear.Review of the archive data indicated on (b)(6) 2018, the device was powered on for a duration of 3 seconds and then power off by the user, however, the user advisory (ua) 45 error message was observed in the archive on dec 10, 2018.The platform was tested with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient with good known test batteries until discharged and passed initial functional testing.Following the service and repair, the autopulse was tested functionally and passed successfully with no issue or faults observed.Device history record (dhr) was 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 the patient use, the autopulse platform operated with continuous compression for 10 minutes and displayed a user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message.Troubleshooting was attempted by realigning the lifeband and ensuring that the driveshaft is in its home position.The length of troubleshooting delay was not specified.The user was unable to clear the error.Manual cpr was immediately performed for an unknown period of time.No known impact or patient consequence information was provided.After the call, the platform was checked one more time at the hospital, and the user was able successfully clear the user advisory (ua) 45 error message after re-attaching the lifeband to the platform.The instructions for clearing the user advisory (ua) 45 were provided to the customer by the zoll technical support.See mfr 3010617000-2019-00018 for the issue with the second patient.

• 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: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 8233966
• MDR Text Key: 133124443
• Report Number: 3010617000-2019-00017
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 12/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2011
• 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