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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Unexpected Shutdown (4019)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

The autopulse platform (b)(4) was used to resuscitate a patient in cardiac arrest.The platform powered off after performing 2 compressions.The crew switched to manual cpr.After the platform was powered on, the device displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.In addition, per the reporter, they noted a loose copper pin in the battery compartment not allowing the battery to be inserted correctly.The crew continue performing the manual cpr during the patient's transport to the hospital.No consequences or impact to patient.Per the reporter, the autopulse battery worked as designed without any issue.Per additional information received from the customer, the loose copper pin was noted by the crew a month before the last call.Per the reporter, the crew was able to temporarily fix the problem and during the shift checks, the platform was functional.

Manufacturer Narrative

The reported complaint that "the autopulse platform (sn (b)(6)) powered off was confirmed during functional testing and based on the archive data review.The archive data indicated multiple incidents of the device shutting off.The root cause for the reported issue was due to one of the battery cable power pins being damaged/loose, likely attributed to user mishandling.The damaged/loose battery cable power pin will interrupt the power delivered to the platform.The secondary complaint of the autopulse platform displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large)" was confirmed based on the archive data review.The reported (ua) 07 advisory message could not be replicated during the device evaluation.The load cell characterization test confirmed both load cell modules were functioning within the specification.The likely root cause for the reported complaint was either due to the patient being out of position or the patient is not properly centered, likely attributed to user error.Per the autopulse maintenance guide and autopulse user advisory list, user advisory (ua) 07 occurs when the load sensing system has detected a weight/load imbalance between the two load cells.The device does not need to be performing compressions for this to occur; it may happen at any time when the device is powered on.User advisory (ua) 07 is an indication that the patient is out of position or the patient is not properly centered.The recommended actions to take for this type of user advisory are: ensure the patient is properly aligned, deploy the shoulder restraint to reduce patient movement, and press restart to clear the ua.The customer reported complaint of a loose copper pin in the battery compartment was confirmed during the visual inspection and the functional testing.Upon visual inspection, noticed one of the battery cable power pins was damaged/loose, thus confirming the customer complaint.The battery cable was replaced to remedy the issue.In addition, unrelated to the reported complaint, noticed the front enclosure at the front-end area and the bottom enclosure at the screw well area was observed cracked and appeared to be the characteristics of user mishandling such as a drop.The front and bottom enclosures were replaced to remedy the observed issue.Also, unrelated to the reported complaint, noticed a head restraint wires were cut.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.Missing head restraints do not render the autopulse platform non-functional.The noted physical damage to the top cover appeared to be the characteristic of user mishandling.The top cover was replaced to address the damage.The initial functional testing of the platform could not be performed because the autopulse platform failed to power on due to the damaged battery power cable.Thus confirming the customer complaint.A review of the archive data showed multiple user advisory (ua) 07 advisory messages.In addition, noticed the archive log was corrupted due to the multiple platform shut down without any compressions performed during numerous sessions, likely attributed to the damaged battery cable.Following the service repair, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged 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 autopulse with serial number (b)(6).

• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131
• MDR Report Key: 12638118
• MDR Text Key: 276584226
• Report Number: 3010617000-2021-00932
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 12/02/2021

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2010
• 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