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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

The customer had sent the autopulse platform (sn (b)(6)) to zoll for evaluation.During service on (b)(6) 2023, the autopulse platform displayed user advisory (ua) 20 (position out of range).The root cause for the (ua) 20 error message was due to the driveshaft not being at the home position, most likely attributed to unintended user error.In addition, the platform failed the load cell characterization check during further functional testing.The root cause was due to a defective load cell.The damaged enclosures and defective load cell were likely attributed to mishandling such as a drop.Upon visual inspection, noticed a damaged top cover and bottom enclosure, and a cracked front enclosure, likely caused by mishandling such as a drop.The damaged top cover, front, and bottom enclosures were replaced to address the observed physical damage.In addition, observed the encoder drive shaft does not rotate smoothly, and exhibits binding and resistance due to a sticky clutch plate.The sticky clutch plate was deburred to address the issue.The cause for the sticky clutch could be due to normal wear and tear.The autopulse platform displayed a (ua) 20 error during the initial functional testing.To remedy the (ua) 20 error, the driveshaft was rotated back to the home position.Upon further testing, the platform failed the load cell characterization test due to a failure of load cell module 2.The load cell was replaced to remedy the issue.A review of the archive data showed the presence of the(ua) 02 (compression tracking error) message, which was determined to be related to the malfunctioning load cell module 2.In addition, the archive data showed (ua) 17 (motor on for too long during active operation), however, the error could not be duplicated during the functional testing.The brake gap inspection was performed and verified the brake gap was within the specification.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.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 the autopulse platform with (b)(6).

Event Description

During service on (b)(6) 2023, the autopulse platform (sn (b)(6)) displayed user advisory (ua) 20 (position out of range) and failed the load cell characterization test.No patient involvement.

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18137517
• MDR Text Key: 328119505
• Report Number: 3010617000-2023-00975
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/14/2023

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: 10/16/2023
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2020
• 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