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 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4)) displayed user advisory (ua) 12 (lifeband not present) error message" was confirmed based on the archive data review but was not confirmed during the functional testing.No device malfunction was observed that could have caused or contributed to the reported ua12 error message.The probable root cause for the reported complaint could be due to the belt clip not detected in spool shaft and/or not fully inserted when the autopulse was powered on, most likely attributed to user error.The reported complaint of "a rattling noise was heard from the inside of the autopulse when the platform was moved up and down or from side to side" was confirmed during the functional testing.The root cause was due to a broken piece of a plastic screw boss from the top cover, as a result of user mishandling.The broken piece was removed to resolve the issue.During visual inspection, it was noted that the battery spring guide on the autopulse platform was bent and lifted off the surface of the top cover.The observed damage was unrelated to the reported complaint, likely attributed to user mishandling.The battery spring guide was replaced to address the issue.Unable to perform functional testing due to the bent battery spring guide, as the battery could not be fully inserted into the battery bay to power up the platform, unrelated to the reported complaint.After replacing the damaged battery spring guide, the platform passed functional testing with no faults or error, and therefore, the reported complaint of ua12 could not be replicated.During further device evaluation, the belt switch assembly was evaluated as a possible root cause for ua12; however, it was observed within the specification.A review of the autopulse platform archive was performed, and it showed ua12 (lifeband not present) error message to have occurred on the customer's reported event date; thus, confirming the reported complaint.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 (ua) 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.Following service, the autopulse 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 brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.

Event Description

During testing the autopulse platform (sn: (b)(4)) with a training lifeband and a manikin, the platform displayed user advisory (ua) 12 (lifeband not present) error message.The user tried multiple lifebands to clear the error code, but the attempts were unsuccessful.In addition, the user reported hearing a rattling noise inside the autopulse when the platform was moved up and down or from side to side.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: 10242616
• MDR Text Key: 198015346
• Report Number: 3010617000-2020-00676
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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: 06/23/2020
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2018
• 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