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 Patient Involvement (2645)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart), user advisory (ua) 18 (max take-up revolution exceeded) and user advisory (ua) 20 (position out of range) error messages was confirmed based on the archive data review, but not during the functional testing.No device malfunction was observed during the testing and the platform worked as intended.The archive data review showed the occurrence of multiple user advisory (ua) 45, user advisory (ua) 20, and advisory (ua) 18 error messages around the reported event date, and the errors were cleared by the customer.User advisory is a clearable error message, user advisory (ua) 45 alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruction, to clear user advisory (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.If the user advisory (ua) 45 error message is not resolved properly, it leads to user advisory (ua) 20 because the drive shaft is not restored at the home position.To remedy the issue, the driveshaft needs to be rotated back to the home position.The user advisory (ua) 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.The autopulse platform passed the initial functional testing without any fault or error.Upon further testing, unrelated to the reported complaint, observed defective membrane switch on the user control panel and the drive train motor brake gap was out of specification due to loose screws as a result of normal wear and tear for the age of the device.The membrane switch needs to be replaced and the brake gap to be adjusted to remedy the fault.The autopulse platform is a reusable device and was manufactured in march 2014 and is almost 6 years old, beyond the expected service life of 5 years.The platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient with good known test batteries and passed all functional testing criteria and met all required specifications.The autopulse platform passed the load cell characterization check.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.

Event Description

During shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message after performing several compressions.In addition, the platform displayed user advisory (ua) 18 (max take-up revolution exceeded) and user advisory (ua) 20 (position out of range) error messages.No patient involvement.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192955
• MDR Report Key: 10161028
• MDR Text Key: 195426626
• Report Number: 3010617000-2020-00602
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/16/2020

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• 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