MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

During patient use, customer reported that the lifeband would not retract, and the autopulse platform (serial # (b)(4)displayed "realigned patient" error message.In addition, the drive shaft makes a grinding/squeaking noise.Crew was unable clear the error and performed manual cpr.Patient's status information was requested but the customer did not provide a response.Please see the following related mfr report: mfr (b)(4) for the lifeband (lot #unknown).

Manufacturer Narrative

The customer reported that "the autopulse platform (serial #(b)(4) displayed "realigned patient" error message and the drive shaft makes a grinding/squeaking noise were confirmed during the functional testing and archive data review.The root cause for both issues were due to a defective drive train motor (slipped bushing) likely due an aging device.The autopulse platform was manufactured in april 2015 and is 7 years old, past its service life of 5 years.Upon visual inspection, no physical damage was observed on the autopulse platform.The archive data indicated multiple fault code 16 on and around the customer reported event date.The fault code 16 occurred due to the autopulse platform did not achieved the target depth for take-up within the specified time (~5 secs) and also caused it to prompts "re-alignment patient", and the drive shaft to make a grinding/squeaking noise, thus confirming the reported complaint.The autopulse platform failed initial functional testing due to fault code16 displayed upon powering on; unrelated to the reported complaint.The root cause of fault code16 error was due to a defective drive train motor (slipped bushing).The drive train motor/clutch was replaced to remedy the fault code16 error.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with sn (b)(4).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15126771
• MDR Text Key: 297222421
• Report Number: 3010617000-2022-00902
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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