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 Patient Involvement (2645)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4)) does not power on with multiple autopulse li-ion batteries" was not confirmed during the functional testing and the 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 device 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 3 good known test batteries without any fault or error.

Event Description

During shift check, the customer reported that the autopulse platform (sn (b)(4)) does not power on with multiple autopulse li-ion batteries.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: 10081363
• MDR Text Key: 193125059
• Report Number: 3010617000-2020-00513
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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: 05/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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