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 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform displayed 'replace battery' error message and powered down" was confirmed based on the analysis of the archive data but was not confirmed during the functional testing.No device malfunction was observed during device evaluation, and the platform functioned as intended.The archive data showed the following user advisories (ua) to have occurred on the customer's reported event date: ua01 (low battery warning), ua17 (max motor on time exceeded during active operation), and ua45 (drive shaft not at home position).The user advisories could not be replicated during the functional testing, and they were cleared by the customer on the reported event date.Upon visual inspection, no physical damage was observed on the returned autopulse platform.A review of the archive data showed one incident of "battery lost" error recorded on the customer's reported event date.Based on the archive, a fully charged battery (sn: 55980), with remaining capacity (rc) of 1424 mah, was used to power up the autopulse platform.The autopulse was powered on and performed 3 sessions of 254, 289, and 13 compressions.Then, the autopulse stopped compressions due to ua01 (low battery warning), followed by ua17 (max motor on time exceeded during active operation) error messages.Ua01 (low battery warning) is triggered when there is less than 5 minutes of active operation left before the battery is too low to operate.However, based on the archive data, the battery (sn: (b)(4)) was still fully charged (rc of 1187 mah) when the issue occurred.A possible root cause for the occurrence of ua01 could be that the autopulse was attempting to draw more power from the battery than what the battery can deliver.This would cause the rc of the battery to momentarily drop below the operational threshold, triggering a low battery warning error message.When compressions are paused for a short period of time, the battery can quickly recover and show a normal charge level again.A user advisory 17 error message is triggered when the motor is on for too long during active operation, and the autopulse platform does not reach the target depth within the specification due to the stiffness of the patient's chest.After the platform stopped compressions and displayed ua01 and ua17, it powered down; thus, confirming the customer's reported complaint.The user pressed re-start and the error messages were cleared.The autopulse performed 129 compressions, and then, the platform stopped compressions and displayed ua45 error message.The archive shows that the platform stopped a few times due to the ua45, but the user managed to clear the error message each time.Eventually, the autopulse performed a total of 1282 compressions with no further interruptions.User advisory 45 occurs when the driveshaft is not at "home" position, most likely attributed to unintended user error; the error message can be cleared by positioning the driveshaft to "home" position.User advisory is the clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse maintenance guide, user advisory 01 indicates that battery needs to be charged because less than 5 minutes of battery voltage is left.The recommended action is to take for this type of user advisory is replace the battery and/or press restart to clear the ua.Per the battery hangtag - advisory codes description and action, user advisory 17 is an indication that the lifeband is twisted or battery voltage is low.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, check battery and lifeband, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.Per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45) pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.The returned autopulse platform passed the initial functional testing without any fault or error.During further functional testing, 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 for approximately 15 minutes, and the platform passed the test without any fault or error.Therefore, the customer's reported complaint could not be confirmed.Following service, the platform passed all testing criteria.

Event Description

A fully charged autopulse li-ion battery was placed in the autopulse platform (sn: (b)(4)) to resuscitate a patient in cardiac arrest.The autopulse performed a few successful compressions for about 5 to10 minutes.However, after administering the first defibrillation shock to the patient, the platform displayed "replace battery" error message and powered down.The user removed the battery and confirmed that the battery was still fully charged.Subsequently, the user re-inserted the battery back into the platform, and the autopulse was powered back on and performed compressions.As per the customer, to avoid further potential device interruptions, the ems crew decided to power down the autopulse each time prior to administering defibrillation shocks to the patient.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: 10276881
• MDR Text Key: 198904634
• Report Number: 3010617000-2020-00689
• 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: 07/15/2020

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: 06/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2020
• 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