MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the zoll platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

As reported, during device check, the autopulse platform (sn (b)(4)) intermittently does not power on when the power button was pressed.Per reporter, the fully charged battery was used prior to inserting into the platform.In addition, second battery was used for troubleshooting with the same results.No patient involvement.

Manufacturer Narrative

The customer reported complaint for the autopulse platform intermittent powering on issue when was not confirmed during the initial functional testing and the archive review.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.As part of routine service during testing, the platform was examined and found cracked/damaged front cover, unrelated to the reported complaint.The autopulse passed the initial functional test without any fault or error.No discrepancies were found in the archive data.The platform was functionally tested and operated as intended.The platform passed all testing specifications with no further issue observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints for autopulse sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8136281
• MDR Text Key: 129475460
• Report Number: 3010617000-2018-01237
• 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,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• 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: 12/12/2018
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1