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 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4)) stopped compressions and displayed the 'realign patient' error message" was not confirmed during the review of the archive data and during the functional testing.The autopulse platform passed the initial functional testing without any fault or error.No device malfunction was observed during the testing, and the autopulse platform functioned as intended.Visual inspection of the returned autopulse platform revealed a cracked front enclosure at the front-end area of the platform.The observed physical damage is unrelated to the reported complaint, and the root cause is most likely attributed to user mishandling.The front enclosure was replaced to address the issue.A review of the autopulse platform archive was performed and revealed that the platform was powered on, but no compression was initiated on the customer's reported event date of (b)(6) 2020.Per archive, the last time the autopulse platform was used to compress an object similar to a human was on (b)(6) 2020, on which date, the platform stopped compressions four times due to the user advisory (ua) 17 (max motor on time exceeded during active operation) error message.The ua17 error code is triggered when the motor was on for too long during active operation.The autopulse did not reach the target depth within the specification time.This normally is experienced when the patient's chest is so stiff and hard to compress.The autopulse platform passed the functional testing, and the reported complaint was not confirmed.During further functional testing, it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which 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.The sticky clutch plate was deburred to address the issue.Following service, the autopulse platform passed multiple run_in tests using the 95% large resuscitation testing fixture (lrtf) with good known test batteries, until discharged without any fault or error.The autopulse has passed all the testing and meets all required specifications.

Event Description

During patient use, the autopulse platform (sn: (b)(4)) performed a few successful compressions for about 5-15 seconds.Then, the platform stopped compressions and displayed "realign patient" error message.The ems crew re-adjusted the lifeband, realigned the patient, and re-started the autopulse platform; however, the issue was not resolved.The user stopped using the autopulse platform and switched to manual cpr immediately.No consequences or impact to the patient.

• 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: 10439649
• MDR Text Key: 204572593
• Report Number: 3010617000-2020-00810
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2019
• 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