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

Model Number MODEL 100

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4)) powers on but crew noticed that the power button was stuck (pushed in) was confirmed during visual inspection.The investigation findings revealed a broken power button bracket as a result of wear and tear and/or mishandling.The autopulse platform is a reusable device and was manufactured in march 2008 and is 12 years old, well past beyond its expected serviceable life of 5 years.The power button bracket needs to be replaced to address this issue.Unrelated to the reported complaint, a cracked top cover ad bottom enclosure were observed on the returned autopulse platform during visual inspection.The observed physical damages are to be the characteristics of mishandling such as drop.The covers will be replaced to address these damaged parts.Initial functional testing on the returned autopulse platform passed without error or fault.Awaiting service repair upon customer's approval.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint for autopulse with serial # (b)(4).

Event Description

During morning shift check, customer reported that the autopulse platform (serial # (b)(4)) powers on but crew noticed that the power button was stuck (pushed in).Crew had to pull the autopulse li-ion battery out to shut down the device.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: 10126034
• MDR Text Key: 194332526
• Report Number: 3010617000-2020-00568
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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