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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the battery port of the autopulse platform sn (b)(6) was bent when the stuck autopulse li-ion battery sn (b)(6) was removed was confirmed during visual inspection.Based on the pictures provided by the zoll service team and customer, the battery connector inside the battery compartment was damaged/bent.The probable root cause was attributed to user mishandling.Per the customer, the damaged battery was "jammed" into the platform.When a battery with a pre-damaged connector is inserted into the battery compartment, and the connector in the battery compartment will be damaged and the battery will be very hard to remove.Per the autopulse power system guide: do not force a connection if you cannot easily connect battery to either the battery charger or the autopulse platform.If the battery is damaged, do not attempt to place the battery into the autopulse platform.This can cause damage to the internal connector of the autopulse platform.During further visual inspection, the front cover was found cracked at the front-end area and the bottom cover had a crack at the handle area.The observed physical damage was unrelated to the reported complaint, and appeared to be the characteristics of user mishandling.The front and bottom covers will be replaced to address the issue.Also unrelated to the reported complaint, one of the head restraint wires on the top cover was heavily frayed.The damaged head restraint does not render the autopulse platform non-functional.The likely root cause for the issue was due to mishandling, but contribution from wear and tear due to age cannot be ruled out.The autopulse platform was manufactured in 2013 and is 10 years old, past its expected service life of 5 years.The top cover will be replaced to address the reported complaint.Upon review of the archive data, no significant discrepancies were found.The autopulse platform passed the initial functional testing without any fault or error.Unrelated to the reported complaint, when the front and bottom covers were removed, blood ingress was observed.The interior of the autopulse is required to have bio-cleaning to resolve the issue.Upon service completion, the console 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 was no previous history of complaints reported for autopulse platform with serial number (b)(6).

Event Description

The customer reported during shift check, the battery port of the autopulse platform sn (b)(6) was bent when the autopulse li-ion battery sn (b)(6) was removed.The battery had been jammed into the device.The battery was stuck, and the customer sent the platform to their clinical engineering department for removal.They are unsure if the platform can be powered on with the damaged battery.No patient involvement.Please see the following related mfr report: for the autopulse li-ion battery.

• 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: 18384905
• MDR Text Key: 331241389
• Report Number: 3010617000-2023-01066
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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: 12/22/2023

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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