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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Noise, Audible (3273)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4) ) made a clicking sound upon powering up" and "sometimes, the lcd display powers up with lines going across the screen" was confirmed during functional testing.The root cause of the reported complaint was the defective processor board, likely due to a defective component.There was no physical damage observed on the returned autopulse platform during the visual inspection.A review of the autopulse platform archive could not be performed because the archive data could not be recovered.The root cause was due to the defective processor board not booting up.During functional testing, the autopulse platform made a clicking sound and failed to boot up due to the defective processor board; thus, confirming the reported complaint.After the autopulse platform powered up, the lcd display was inspected, and no issues were found with the display.However, findings revealed that the processor board was defective, which resulted in the lcd display to intermittently show lines going across the screen; thus, confirming the customer's reported complaint.The processor board was replaced to remedy the fault.Following service, the autopulse 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 platform with serial number (b)(4).

Event Description

During patient use, the autopulse platform (sn: (b)(4)) made a clicking sound upon powering up.As per the customer, the clicking sound was heard both prior to and after installing the lifeband.The ems crew switched to manual cpr to finish the call.No consequences or impact to the patient.It was also reported that sometimes, the lcd display powers up with lines going across the screen, and thus, resulting in the lcd to become unreadable.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(6)) failed to power up" was confirmed during functional testing.The autopulse platform failed to boot up due to the defective processor board, and it was replaced to remedy the fault.

Event Description

During patient use, the autopulse platform (sn: (b)(6)) made a clicking sound and failed to power up.As per the customer, the clicking sound was heard both prior to and after installing the lifeband.The ems crew switched to manual cpr to finish the call.No consequences or impact to patient.It was also reported that sometimes, the lcd display powers up with lines going across the screen, and thus, resulting in the lcd to become unreadable.

• 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: 11103313
• MDR Text Key: 226854906
• Report Number: 3010617000-2020-01308
• 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: 01/13/2021

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: 12/16/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1