MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Event Description

During shift check, the autopulse platform's (sn (b)(4)) display illuminated orange and red warning lights and was alternating between on and off.The customer provided no further information.No patient involvement.

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform's (sn (b)(4)) display illuminated orange and red warning lights and was alternating between on and off " was confirmed during the functional testing.The root cause for the customer-reported complaint was a defective pdb (power distribution board), likely attributed to the device's aging.The autopulse platform was manufactured in 2008 and is 13 years old, well past the expected service life of 5 years.Upon visual inspection, unrelated to the reported complaint, noticed that one of the head restraints on the top cover was cut.The cut head restraint does not render the autopulse platform non-functional.The patient head restraint wire could have been cut to free the patient from the platform, or the user could have been lifting the platform by holding the head restraints.In addition, unrelated to the reported complaint, noticed a cracked front enclosure.The likely root cause for the observed physical damages is attributed to user mishandling.The top cover and the front enclosure were replaced to address the physical damages.The autopulse platform was powered on and immediately powered off by itself during functional testing, thus confirming the customer reported complaint.The pdb was replaced to address the reported complaint.After replacing the pdb, the autopulse platform passed the functional testing using the large resuscitation test fixture (lrtf) with good known test batteries for 30 minutes without fault or error.Following service, the autopulse platform passed the run-in test using the 95% patient 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.A load cell characterization test was performed and confirmed that both cell modules function within the specification.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 previous history of complaint reported for autopulse platform with sn (b)(4).

• 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: 12716346
• MDR Text Key: 282338528
• Report Number: 3010617000-2021-01001
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• 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,foreig
• Type of Report: Initial
• Report Date: 09/28/2021

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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1