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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281); Noise, Audible (3273)

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

Event Date 08/29/2022

Event Type  malfunction  

Event Description

During the morning shift check, the lcd of the autopulse platform (sn (b)(4) showed a thin black line, and the platform made a clicking sound.The customer rebooted the autopulse platform; however, the issue persisted.Upon rebooting the autopulse platform for the third time, the platform displayed a "system error, out of service, revert to manual cpr" message.The customer tried to clear the error message by swapping the battery and the lifeband, but the issue persisted.No patient involvement.

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (sn (b)(4) displayed a "system error, out of service, revert to manual cpr," which was confirmed during functional testing and archive data review.The reported complaint of "a thin black line on the lcd, and the platform made a clicking sound" was not verified during the functional testing.However, the root cause for the customer's reported complaints was determined to be related to the internal component error or malfunction of the processor board.Upon visual inspection, unrelated to the reported complaint, zoll service personnel noted a hole on the load plate cover that affected the watertight seal.The root cause of the observed physical damage was likely user mishandling.The load plate cover will be replaced to address the observed physical damage.The archive data review indicated system error 132 (internal watchdog timeout), thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device, confirming the reported complaint.The processor board will be replaced to address the reported complaint.Zoll is awaiting customer approval for service repair.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 sn (b)(4).

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15481463
• MDR Text Key: 303319978
• Report Number: 3010617000-2022-01663
• 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
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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: 09/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• 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 Outcome(s): Hospitalization