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 Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of autopulse platform (sn (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 ua 07 was due to defective load cells.The defective load cells were likely due to a defective component or mishandling such as drop.During visual inspection, no physical damage was observed.During archive data review, multiple ua 07 error messages were recorded around the reported event date, thus confirming the reported complaint.During the functional testing, the platform's load sensing system has detected a weight/load imbalance between the two load cells (checked during power-on-self-test).Load cell characterization results confirmed load cells over reported (defective).Thus, confirming the reported complaint.To remedy ua 07, damaged load cells were replaced.After replacing load cells, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The load cell characterization test passed.The autopulse platform passed final test.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).

Event Description

During device check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.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
• 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: 10463761
• MDR Text Key: 205013429
• Report Number: 3010617000-2020-00826
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: 08/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2013
• 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