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

Model Number MODEL 100

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During shift check, customer reported that the lifeband could not be lifted up on the autopulse platform (serial #(b)(4)).About 10 seconds later, the lifeband was able to be easily lifted up.The same was observed when the autopulse platform was powered off.No patient involvement.

Manufacturer Narrative

The reported complaint of the lifeband could not be lifted up on the autopulse platform (serial #(b)(4) was not confirmed.No issues found during functional testing.The autopulse platform functions properly as intended.No physical damaged on the returned autopulse platform was observed during visual inspection.The returned autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged.The autopulse platform passed all the functional tests and it is ready for clinical use.

• 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: 8756246
• MDR Text Key: 149928776
• Report Number: 3010617000-2019-00552
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2019
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1