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 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4) has small tears on the load plate cover was confirmed during visual inspection.The root cause for the reported damage was due to mishandling.Additional issues were observed during visual inspection were cracked front enclosure and a battery lock.The root cause of the physical damages was likely due to mishandling such as drop.The clutch was observed to be sticky due to wear and tear.These observations are not related to the reported complaint.As part of routine service during testing, the platform was evaluated.Upon initial functional testing, the platform displayed a "system error, out of service, revert to manual cpr" message.The archive data showed that the observed systerm error was user advisory (ua) 139 (unable to hold compression position) and the root cause was due to a defective motor controller board due to wear and tear.Autopulse platform is a reusable device and was manufactured on 08 november 2013 and has exceeded its expected service life of five years.After deburring of the clutch and replacing the load plate cover, front enclosure, battery lock and motor controller board, 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.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 shift check, the autopulse platform (sn (b)(4) was observed with small tears on the load plate cover.No patient involvement.The platform was returned to zoll for service and on (b)(6) 2020, the autopulse platform (sn (b)(4) failed initial functional testing and displayed "system error, out of service, revert to manual cpr" message on the user control panel.

• 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: 10497550
• MDR Text Key: 208940635
• Report Number: 3010617000-2020-00855
• 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: 09/03/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2013
• 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