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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (b)(4) displayed user advisory - "(ua)17" (max motor on time exceeded during active operation) error message was confirmed during functional testing and during archive data review.The root cause of the ua17 error message was due to the brake gap out-of-specification in which is likely attributed to normal wear and tear.The autopulse platform was manufactured in january 2015 and has reached its expected serviceable life of 5 years.The secondary customer reported complaint of the autopulse platform abruptly powered off after displaying ua17 was not reproduced during the functional testing.The archive data indicated that the autopulse platform last power up was on (b)(6) 2021 with a ua17 error.The autopulse li-ion battery (b)(4) used was returned and evaluated, the archive data indicated that on (b)(6) 2021, the customer inserted the battery in the autopulse platform and the battery was remained in the platform for about to 8.7 days and was discharged to about to one amber light on the battery status bar.The battery may had low voltage capacity and could have possibly caused the autopulse platform to powered off during the training.Upon visual inspection, unrelated to the reported complaint, the zoll service personnel noticed a cracked front enclosure.The observed physical damage appeared to be the characteristics of the harsh impact caused by user mishandling, such as a drop.The damaged cover was replaced to address this issue.The archive data indicated three ua17 errors around the reported event date, thus confirming the reported complaint.During initial functional testing, the returned autopulse platform displayed a "ua17" error message, thus confirming the reported complaint.The root cause of the error was due to the drive train motor brake gap was out-of-specification.The brake gap was cleaned and adjusted to the manufacturing specifications to remedy the error message.Following service, the autopulse platform passed 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 brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed the final testing 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 platform with a serial number (b)(4).

Event Description

During training check, customer reported that the autopulse platform (b)(4) displayed user advisory - "(ua)17" (max motor on time exceeded during active operation) error message and abruptly power off.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 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: 13054703
• MDR Text Key: 282624786
• Report Number: 3010617000-2021-01194
• 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: 12/21/2021

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: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2015
• 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