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

Model Number MODEL 100

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 22 june 2020 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

During patient use, the autopulse platform (sn: (b)(4)) screen lcd was observed cracked.Later during shift check, it was noted that the battery lock was broken, and thus, the battery would fall out of the platform.Also, a crack was noted at the top of the battery compartment.No further information was provided.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(6) lcd screen was observed cracked" was not confirmed during visual inspection and functional testing.No device malfunction was observed, and the autopulse platform lcd screen was readable and functioned as intended.The reported complaint of "the battery would fall out of the platform, and it was suspected that the battery lock on the autopulse platform was broken" was not confirmed during visual inspection and functional testing of the returned autopulse platform.No device malfunction was observed, and the platform functioned as intended.The possible cause for the battery to fall out of the autopulse platform could be due to a potential battery damage, such as a broken guide pin.The reported complaint of "a crack was noted at the top of the battery compartment" was confirmed during the visual inspection of the returned platform.A large crack was observed on the top cover, at the upper corner, on the patient's left-hand side of the autopulse platform.The root cause of the observed damage could be due to normal wear and tear and/or due to user mishandling.The autopulse platform is a reusable device and was manufactured in august 2014, and it is almost 6 years old, exceeded its expected service life of 5 years.The top cover was replaced to address the issue.Upon further visual inspection, unrelated to the reported complaint, it was noted that the bottom enclosure of the returned autopulse platform was slightly scratched and chipped in few locations.In addition, there were a few small cracks observed near the edges of the bottom enclosure.The root cause of the observed physical damages could be due to normal wear and tear and/or due to user mishandling.The bottom enclosure was replaced to address the issue.A review of the autopulse platform archive was performed, and no significant discrepancies were observed.The autopulse platform passed the functional testing without any fault or error.Unrelated to the reported complaint, it was noted that the platform's clutch was extremely sticky.Investigation findings revealed that the root cause of the sticky clutch was due to the clutch have been worn out, and therefore, it was replaced to remedy the fault.Following service, including replacement of all the damaged parts, 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.

Event Description

During patient use, the autopulse platform (sn: (b)(6) lcd screen was observed cracked.No further information was provided by the customer, and therefore, it is unknown if the lcd display was readable or not.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.Later during shift check, while testing the device, it was noted the battery would fall out of the platform, and it was suspected that the battery lock on the autopulse platform was broken.In addition, a crack was noted at the top of the battery compartment.

Event Description

During patient use, the autopulse platform (sn: (b)(6)) lcd screen was observed cracked, and therefore, the customer took the platform out of service.No further information was provided by the customer.It is unknown if the lcd display was readable or not.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.Later during shift check, while testing the device, it was noted the battery would fall out of the platform, and it was suspected that the battery lock on the autopulse platform was broken.In addition, a crack was noted at the top of the battery compartment.

Manufacturer Narrative

B5 (describe event or problem) was corrected.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10185901
• MDR Text Key: 196298630
• Report Number: 3010617000-2020-00621
• 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,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• 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
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1