MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) displayed user advisory (ua) 17 (max motor on-time exceeded during active operation) error message was not confirmed during archive data review or functional testing.Based on the archive, the customer likely reported the wrong user advisory number, as no (ua) 17 errors were observed in the archive data.The customer complaint that the driveshaft was stuck was confirmed during visual inspection and functional testing.The driveshaft was very difficult to turn, related to the very sticky driveshaft clutch area.This is usually caused by sharp edges from all 12-hex edges of the armature plate, or due to burrs on the clutch rotor's surface, likely attributed to normal wear and tear.The autopulse platform was manufactured in 2016 and is 7 years old, past its expected service life of 5 years.Upon further visual inspection, unrelated to the reported complaint, a cracked front enclosure, bent battery lock, and a damaged battery connector were observed.The observed physical damage appeared to be the characteristics of user mishandling.The front enclosure, battery lock, and battery cable will be replaced to address the issues.A review of the archive file showed user advisory (ua) 20 (position out of range), (ua) 16 (timeout moving to take-up position), and (ua) 45 (not at "home" position after power-on/restart) error messages, unrelated to the reported complaint.The autopulse platform failed initial functional testing due to the displayed (ua) 45 error message, unrelated to the customer's reported complaint.The driveshaft was returned to the home position using the administrative menu to remedy the (ua) 45.The root cause for the (ua) 45 error was due to the driveshaft not being at "home position." the error message can usually be easily cleared by pulling up the lifeband until the chest bands are fully extended to move the driveshaft to its home position.However, in this case, the driveshaft was very difficult to turn, due to the sticky clutch plate.The clutch plate was replaced to remedy the issue.The brake gap was adjusted to specification as a precaution against the (ua) 16 error observed in the archive (gap was at.009, spec.Is.008).The (ua) 20 observed in the archive was not reproduced.The device subsequently passed a 15-minute functional test with the large resuscitation testing fixture, (lrtf) equivalent to a 250-pound patient.Per autopulse user advisory list guide, user advisory (ua) 20 occurs due to the encoder driveshaft not being within the normally acceptable range of positions.Typically, if the user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) is not resolved properly, it leads to ua20 because the driveshaft is not restored at its "home" position.To clear a ua20, return the driveshaft to its "home" position using the platform's administrative menu.Upon service completion, the platform will be subjected to final functional testing to ensure that the device passes all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with (b)(6).

Event Description

The customer reported the autopulse platform (b)(6) displayed user advisory (ua) 17 (max motor on-time exceeded during active operation) error message and the driveshaft is stuck.Zoll tech support walked the customer through resetting the driveshaft, but the (ua) 17 persisted.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18044342
• MDR Text Key: 327430460
• Report Number: 3010617000-2023-00930
• 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: 10/31/2023

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: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• 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