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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the autopulse platform stopped compressions and displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) error message was confirmed during archive review and not during the initial functional testing.There were no device deficiencies found during the evaluation of the returned platform that could have caused or contributed to the reported complaint.No device malfunction was observed, and it performed as intended.Based on the archive data review, the issue is likely attributed to the stiffness of the patient's chest.Visual inspection of the returned platform was performed and found no physical damage.A review of the archive data indicated user advisory (ua) 17 errors occurred on the reported event date, thus confirming the customer complaint.Based on the archive, the autopulse platform performed 858 compressions on the medium size patient.The device has stopped compressing due to (ua) 17.The user pressed restart to clear the fault and the autopulse platform was used again for 730 compressions and stopped four more times due to (ua) 17 as the driveshaft met resistance due to the stiffness of the patient's chest.The user advisory (ua) 17 error message alerts the user that the drive motor did not reach the target compression depth within specification when used on a medium/large size stiff patient.The reason the autopulse platform stops after a few compressions, it is trying to build-up to the 20% compression depth and cannot do it in the specific time frame but did not have enough power to achieve this compression rate within 0.38 seconds.As a precautionary measure, the brake gap was cleaned and adjusted to address the customer reported (ua) 17 error.The platform was further tested with a large resuscitation testing fixture, (lrtf) equivalent to the (b)(6)-pound patient and passed all functional testing criteria and met all required specifications.

Event Description

During patient use, it was reported that the autopulse platform (sn (b)(4)) stopped compression after 20 minutes of use and displayed user advisory (ua) 17 (max motor on time exceeded) error message.The crew was unable to clear the error message, the platform was stopping after performing compressions 2-3 times.Following this, the crew immediately performed manual cpr.No consequences or impact to patient.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6) showed a pixilated lcd black screen was confirmed during functional testing and visual inspection.The root cause was due to a damaged lcd transmissive module due to fluid ingress caused by to user mishandling.Per autopulse user guide, 4.2.Cleaning the autopulse platform section: "wipe all the surfaces of the autopulse platform free of foreign matter and spills with a disinfectant or bactericidal wipe.Check the vents to ensure that they are free and clear of any obstructive matter.Caution: do not submerge the autopulse in liquid.Ensure that the autopulse is dry before storing." during initial functional testing, the platform was observed with pixilated lcd black screen.During visual inspection, a hole on the load plate cover that affects the watertight seal was observed and after removing the top and the bottom covers of the platform, noticed fluid/blood ingress inside the platform, likely attributed to mishandling.The interior of the autopulse required to have a bio-cleaning.Top cover needs to be replaced due to corrosion on the metalized surface of the top cover.In addition, observed the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate, these observations are unrelated to the reported complaint.The impact of sticky clutch was not severe enough to make the platform non-functional.The probable cause for the sticky clutch could be due to corrosion or could be due to normal wear and tear.The autopulse platform was manufactured in 2007 and is 13 years old, well beyond the expected service life of 5 years,.Waiting for customer's approval for service.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11093755
• MDR Text Key: 224301007
• Report Number: 3010617000-2020-01307
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

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: 12/22/2020
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1