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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaints of the autopulse platform (serial # (b)(4)) displayed fault code 16 (timeout moving to take-up position) was confirmed during initial functional test and archive data review.The investigation findings revealed that the root cause of fault code 16 was due to seized brake gap in which was likely attributed to wear and tear.The autopulse platform was manufactured in september 2013 and is nearly 7 years old, past its expected serviceable life of 5 years.Unrelated to the reported complaint, a cracked front enclosure, torn load plate cover and a bent battery lock were observed during visual inspection.These types of physical damages on the returned autopulse platform were likely attributed to wear and tear and/or mishandling.The damaged enclosure, load plate cover and battery lock were replaced.During archive data review, multiple fault code 16 were identified on the event date.Thus, confirming the reported complaint.Initial functional testing on the returned autopulse platform failed due to fault code 16 (moving to take-up position) displayed upon powering on.Thus, confirming the reported complaint.To remedy fault code 16, the brake gap was un-seized.After service repair completion, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The autopulse platform passed all other functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint for autopulse with serial number (b)(4).

Event Description

Customer reported that the autopulse platform (serial # (b)(4)) displayed fault code 16 (timeout moving to take-up position) error message upon powering on.User did not try to clear error message.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10081186
• MDR Text Key: 191861889
• Report Number: 3010617000-2020-00524
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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