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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the platform however, the investigation is pending.A follow-up report will be submitted when the investigation has been completed.

Event Description

During shift check, customer reported that the autopulse platform (serial # (b)(4)) does not power on with several good fully charged autopulse li-ion batteries.No patient involvement.

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4) does not power on with several good fully charged autopulse li-ion batteries was confirmed during initial functional testing.The root cause of the device's power issue was due to a defective battery cable, likely attributed to wear and tear.The autopulse platform was manufactured in march 2015 and has reach its expected serviceable life of 5 years.Unrelated to the reported complaint, a cracked front enclosure was observed on the returned autopulse platform was observed during visual inspection.This type of physical damage cover was likely attributed to wear and tear and/or mishandling.The front enclosure was replaced.During archive data review, two user advisory (ua) 27 (drive shaft turning too fast during compression) error code occurred on (b)(6) 2019 and (b)(6) 2020.This issue is unrelated to the reported complaint.As a precautionary measure, the encoder gearbox was replaced.Initial functional testing failed due to the returned autopulse platform did not power on.To remedy the power issue, the battery cable was replaced.After service repair completion, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with known good batteries until discharged without any fault or error.The autopulse platform passed all the functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint for autopulse with serial # (b)(4).

• 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: 10089966
• MDR Text Key: 193305155
• Report Number: 3010617000-2020-00525
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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?: Yes
• Date Returned to Manufacturer: 05/19/2020
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1