MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4) ) intermittently powered off was not confirmed during the archived data review or during the initial functional testing.The autopulse platform passed the functional testing and the autopulse platform worked as intended.Visual inspection was performed and observed pieces of white plastic foam in the battery bay that could be a possible cause of the platform's intermittent power loss.In addition, the power button of the platform had evidence of liquid ingress that could also be a possible cause of the power loss.This type of observed issue is likely attributed to mishandling.The foam was removed from the battery bay and as a precautionary measure, the power button and cable were replaced.Also, unrelated to the reported complaint, found a damaged front enclosure as a result of user mishandling such as a drop.The front enclosure was replaced to address the damage.The platform passed the initial functional testing without any fault or error.The archive data review showed no significant discrepancies.Following service, the autopulse platform passed 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 the shift check, the autopulse platform (sn (b)(4) ) intermittently powered off without displaying any user advisories.The user tried multiple batteries, however, the issue persists.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 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 11697995
• MDR Text Key: 247542286
• Report Number: 3010617000-2021-00344
• 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: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• 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: 04/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2017
• 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