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 Patient Involvement (2645)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4)) displayed user advisory (ua)41 (patient temperature sensor failure) error message" was confirmed based on the archive data review but not confirmed during the functional testing.No device malfunction was observed that could have caused or contributed to the reported ua41 error message.A review of the autopulse platform archive revealed that frequent daily checks were performed by the customer, but the storage condition of the platform is not known.Improper storage conditions of the autopulse system most likely contributed to the occurrence of the ua41.Factors such as ambient storage condition (e.G.A fire truck sitting in a hot and humid environment and/or being exposed to direct sunlight for long hours) as well as using the platform on a soft surface that may block air vents will increase the internal temperature of the autopulse platform and could potentially cause the occurrence of the ua41 error message.During the visual inspection, the bottom enclosure was observed to be slightly chipped, and there was a small vertical crack running through one of the screw fittings of the front enclosure.Also, the battery lock was observed bent.The physical damages were unrelated to the reported complaint and appeared to be the characteristics of normal wear and tear and/or user mishandling.The autopulse platform was manufactured in october 2012, and it is over 7 years old, exceeded its expected service life of 5 years.The front and bottom enclosures as well as the battery lock were replaced to address the observed issues.The archive data review showed ua41 (patient temperature sensor failure) error message to have occurred on the reported event date; thus, confirming the reported complaint.Unrelated to the reported complaint, further review of the archive showed user advisory (ua) 18 (max take-up revolution exceeded) and user advisory (ua) 02 (compression tracking error) error messages to have occurred on the reported event date.The error messages could not be replicated during functional testing.The probable root cause for the occurrence of the ua18 was most likely due to no weight on the platform or due to an opened lifeband, likely caused by user error.The probable root cause of the ua02 was most likely due to an opened or twisted lifeband, likely attributed to user error.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, 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.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.The autopulse platform passed initial functional testing without any fault or error, and therefore, the reported complaint could not be replicated.Furthermore, the autopulse was subjected to a run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged for 15 minutes, and the platform passed the test without any fault or error.Nevertheless, the temperature sensor cabling was replaced as a preventive precautionary measure, as the sensor may have had some intermittent technical problems that could not be directly identified during the functional testing.Following service, the platform passed all testing criteria.

Event Description

During shift check, the autopulse platform (sn: (b)(4)) displayed user advisory (ua)41 (patient temperature sensor failure) error message.No patient involvement.

• 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: 10299909
• MDR Text Key: 199712070
• Report Number: 3010617000-2020-00696
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• 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: 06/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• 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