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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During patient use, the autopulse platform was set to continuous mode and switched to manual mode.No further information provided.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.

Event Description

Based on the additional information received from the customer on 12 january 2021, the autopulse platform (sn (b)(6)) functioned as intended.The issue was due to the zoll x series monitor software recognition of autopulse use, occasionally switching back to manual cpr.Therefore, we would like to retract the initial mdr that was submitted on 30 december 2020, mfr 3010617000-2020-01360.

• 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: 11096823
• MDR Text Key: 226856750
• Report Number: 3010617000-2020-01360
• 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: 01/22/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 01/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1