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 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message" was confirmed during the functional testing and based on the archive data review.The root cause of the reported complaint was that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance.Possibly, the user had difficulty pulling the lifeband straps completely up or had difficulty to manually rotate the encoder driveshaft to the "home" position prior to turning on the autopulse platform.The reported complaint of "the top cover was observed cracked after the autopulse platform was dropped by the customer" was confirmed during the visual inspection of the returned platform.A large crack was observed at the corner of the top cover, on the patient's left-hand side.The root cause of the observed physical damage appeared to be the characteristic of harsh impact due to user mishandling, as the platform was dropped by the customer.The top cover was replaced to address the issue.The archive data review indicated multiple user advisory (ua) 45 error messages occurred on the reported event date; thus, confirming the reported complaint.During functional testing, upon powering up the platform, ua45 was displayed.Therefore, the reported complaint was confirmed.During further functional testing, it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance.The root cause was due to sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.The autopulse platform is a reusable device and was manufactured in february 2014, and it is over 6 years old, exceeded its expected service life of 5 years.The sticky clutch plate was deburred to address the issue, and subsequently, the driveshaft was rotated to "home" position to clear the ua45 error message.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 brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.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, while installing an autopulse lifeband, the autopulse platform (sn: 50039) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message.The lifeband was replaced to troubleshoot the problem; however, the issue was not resolved.In addition, the platform was dropped by the customer, and it was noted that the top cover was cracked.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: 10323456
• MDR Text Key: 200433456
• Report Number: 3010617000-2020-00714
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• 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