MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 10/05/2023

Event Type  malfunction  

Event Description

The customer reported the autopulse platform (b)(6) displayed fault code 27 (encoder fault) after a round of cpr on an elderly female patient of normal weight.The crew stated it sounded like the gears inside were stripped when they were using it.It sounded like the gears are no longer making good contact with the band internally and something is worn or broken on the gears.The crew switched to manual cpr.Manual cpr was performed for the duration of the call.Patient's status information was requested but the customer did not provide a response.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) displayed fault code 27 (encoder fault) was confirmed during functional testing and review of the archive data.The complaint of a sound from the gears was also confirmed during functional testing.The root cause of the fault code and sound from the gears was a failure of the integrated encoder gearbox, likely attributed to the age of the device.The autopulse platform was manufactured in 2015 and is 8 years old, past the expected service life of 5 years.Upon visual inspection, unrelated to the reported complaint, a cracked front enclosure was observed.The observed physical damage appeared to be the characteristics of user mishandling, such as a drop.The front enclosure was replaced to address the damage.A review of the archive data showed fault code 27; thus, confirming the reported complaint.User advisory (ua) 34 (encoder failure) was observed, possibly related to the reported complaint.The root cause is related to the encoder gearbox failure.Unrelated to the reported complaint, the archive also showed (ua) 02 (compression tracking error), (ua) 45 (not at "home" position after power-on/restart), and (ua) 18 (max take-up revolution exceeded).The autopulse platform failed initial functional testing due to the displayed fault code 27, confirming the customer's reported complaint.The sound from the gears reported by the customer was also confirmed.The integrated encoder gearbox was replaced to remedy the issues.Unrelated to the reported complaint, a sticky clutch plate was found.The impact of a sticky clutch was not severe enough to make the platform non-functional.The cause for the sticky clutch could be due to normal wear and tear.The clutch was deburred to address the observed problem.(ua) 02, (ua) 45, and (ua) 18 observed in the archive were not reproduced.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.Per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45) pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.Per the battery hangtag - advisory codes description and action, user advisory 18 is an indication that the autopulse® has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.In this case, revert to manual cpr.Following service, the autopulse platform passed the run-in test 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 were no similar complaints reported for autopulse platform with serial number (b)(6).

• 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: 18022212
• MDR Text Key: 326743125
• Report Number: 3010617000-2023-00919
• 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,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2015
• 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
• Patient Sex: Female