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 Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of autopulse platform (serial #(b)(4)) displayed user advisory - "(ua)07" (discrepancy between load 1 and load 2 too large) was confirmed during initial functional testing and archive data review.The root cause for ua7 was due to defective load cells.The cracked cover and defective load cells were likely attributed to mishandling such as a drop.During visual inspection, a cracked front enclosure was observed on the returned autopulse platform, unrelated to the customer reported complaint.The damaged front enclosure is likely attributed to mishandling.During archive data review, multiple ua7 error messages were recorded, thus confirming the reported complaint.The initial functional testing failed due to the returned autopulse platform displayed "(ua)07" upon powering on, thus confirming the reported complaint.To remedy, both defective load cells will be replaced.Awaiting service repair approval from customer.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

During patient use, customer reported that the autopulse platform (serial #(b)(4)) displayed user advisory - "(ua) 07" (discrepancy between load 1 and load 2 too large) on the screen panel.The crew was unable to clear the advisory and immediately performed manual cpr.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10160287
• MDR Text Key: 195425318
• Report Number: 3010617000-2020-00597
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1