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 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the platform is returned and investigation has been completed.

Event Description

During patient use, the autopulse platform (sn (b)(4)) stopped compression and displayed user advisory (ua) 17 (max motor on time exceeded) error message and the autopulse platform had a fully charged autopulse li-ion battery at the time of the issue.Per user, the lifeband was checked and was not twisted.Following this, the crew immediately performed manual cpr.No consequences or impact to patient.

Manufacturer Narrative

The reported event on the autopulse platform (sn (b)(4) displaying user advisory (ua) 17 (motor on for too long during active operation) error message was not reproduced during functional testing; however, was confirmed through the archive data review.The platform performed as intended.No device malfunction.The root cause of the reported issue was due to the stiffness of the patient's chest.Visual inspection of the returned platform was performed and found no physical damage.The archive log file revealed the autopulse stopped compression multiple times due to user advisory (ua) 17.The max load sum and the take-up target indicated the platform was used to compress a medium-size, light in weight and the patient's chest is so stiff and hard to compress.The ua 17 error message was displayed as the driveshaft met resistance due to the stiffness of the patient's chest.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 platform passed all functional tests and is ready for clinical use.User advisory is a clearable error message.Ua17 error message alerts the user that the drive motor did not reach the target depth within specification when used on a medium/large size stiff patient or the lifeband is twisted or battery voltage is low.The recommended actions to take for this type of user advisory are: pull up the lifeband completely, ensure that the patient and the lifeband are properly aligned, check battery and press restart.During a ua 17 error message, the platform is trying to achieve the 20% compression but did not have enough power to achieve this compression rate within 0.38 seconds.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(6).

• 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: 10344283
• MDR Text Key: 201019259
• Report Number: 3010617000-2020-00748
• 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
• Report Date: 09/11/2020

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: 08/17/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1