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)

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

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the lcd screen of the autopulse platform s/n (b)(4) was intermittently dark and unreadable" was not confirmed during functional testing and archive data review.During testing, no device malfunction was found, and the autopulse platform functioned appropriately and as intended.Visual inspection of the returned autopulse platform revealed a damaged front enclosure and a bent battery lock, unrelated to the reported complaint.Based on the photo provided by the zoll service team, one of the handles of the front enclosure was observed to be broken/chipped near its screw fitting area.The observed physical damages were appeared to be the characteristics of harsh impact due to user mishandling.The front enclosure and battery lock were replaced to address the observed damages.A review of the autopulse platform archive was performed, and no significant discrepancies were noted.The autopulse platform passed initial functional testing without any fault or error.During further testing, the customer's reported complaint could not be replicated, as the lcd screen was visible, bright, and readable at all stages of device evaluation.No missing pixels or lines were noted either.Unrelated to the reported complaint, it was noted that the clutch plate was sticky.Sticky driveshaft clutch area is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to frequent use of the device.The impact of the sticky clutch was not severe enough to make the autopulse platform non-functional.The clutch plate was deburred to remedy the problem.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.

Event Description

During a training session, the user reported that the lcd screen of the autopulse platform s/n (b)(4) was intermittently dark and unreadable.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: 12006941
• MDR Text Key: 256485762
• Report Number: 3010617000-2021-00515
• 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: 06/16/2021

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: 06/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• 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