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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2020

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

Customer reported that the loaner autopulse platform (serial #(b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering on.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(6) displayed "system error, out of service, revert to manual cpr" error message during power on was confirmed during functional testing.Zoll canada has declined to service the loaner platform.The platform will be placed aside and labelled as "not for clinical use".No physical damage was observed on the autopulse during visual inspection.

Event Description

During device check, the loaner autopulse platform (serial # (b)(6) displayed "system error, out of service, revert to manual cpr " upon powering on.No patient involvement.

• 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: 10176863
• MDR Text Key: 196296842
• Report Number: 3010617000-2020-00603
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1