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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the product is returned and the investigation has "ben" completed.

Event Description

As reported, the autopulse platform (sn# (b)(4)) displayed ua41 (patient temperature sensor failure) error message.The user noticed damages on the short black cover of the platform.No known impact or consequence to patient information was available.

Manufacturer Narrative

The reported event of the autopulse platform (sn (b)(4) displayed ua41 (patient temperature sensor failure) error message was confirmed during functional testing and based on the archive data review.The root cause for the ua41 error message was due to the defective patient temperature sensor.The reported complaint of the damaged short black cover was confirmed during visual inspection.The root cause of the physical damage was determined to be user handling.Upon visual inspection, noticed sticky clutch plate, unrelated to the customer reported event.The clutch plate was deburred to remedy the issue.The platform failed initial functional testing due to ua41 (patient temperature sensor failure) error message displayed upon powering on.The archive data review showed occurrence of ua41 error message on the customer reported event date.The patient temperature sensor was replaced to remedy the issue.The autopulse was subjected to 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.Following service, the autopulse platform passed final functional test without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8287719
• MDR Text Key: 134454914
• Report Number: 3010617000-2019-00051
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1