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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4) ) for investigation.A follow-up report will be submitted when the product is returned and the investigation has been completed.

Event Description

During patient use, the autopulse platform (sn (b)(4) ) failed to power on.The crew used multiple battery, however issue still occurred.The crew immediately performed manual cpr.No consequences or impact to patient.In addition, after dropping the patient off at the hospital, the crew was able to power on the platform and was unable to reproduce the issues from the prior incident.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6) failed to power on with multiple batteries was not confirmed during functional testing and archive data review.The autopulse platform was powered on successfully during the testing.There were no device deficiencies found during the evaluation of the returned platform that could have caused or contributed to the reported complaint.The platform performed as intended.There was no device malfunction.There was no physical damage observed on the returned autopulse platform during the visual inspection.The archive data review showed no significant discrepancies on the reported complaint date.The autopulse platform passed the initial functional test without any fault or error.The platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with multiple good known test batteries without any fault or error.The platform passed the final testing without any fault or error.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11084939
• MDR Text Key: 226838163
• Report Number: 3010617000-2020-01312
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 12/28/2020

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: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1