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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

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 platform is returned and investigation has been completed.

Event Description

During device check, the autopulse platform (sn (b)(4)) displayed "pull up lifeband and press restart" error message and the drive shaft was not engaging.The user was unable to clear the message.No patient involvement.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4) displayed "pull up lifeband and press restart" error message and the drive shaft was not engaging; was confirmed during functional testing and archive data review.Based on functional testing and archive data review, user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was observed.The root cause for the ua 07 error was due to a defective load cell, likely attributed to mishandling such as a drop or due to a defective component.During visual inspection, there was no physical damage observed on the autopulse platform.The initial functional testing of the autopulse platform could not be performed due to ua 07 error message displayed upon powering on, thus confirming the customer complaint.Review of the archive data indicated error message user advisory (ua) 07.The load cell characterization test revealed that the load cell was over-reporting.The defective load cell needs to be replaced to address the error.After service repair completion, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.The autopulse platform passed the final testing 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 with serial number (b)(4).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10483517
• MDR Text Key: 209357756
• Report Number: 3010617000-2020-00846
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: 11/05/2020

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1