MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

As reported, the autopulse platform (sn (b)(4)) was performing compressions on a (b)(6) male patient in cardiac arrest.The platform performed two rounds of 2 minutes compressions without any issue.The crew paused the platform to check the patient's pulse.During the third round, the platform displayed "re-align band" error message after performing compressions for about 10 seconds.The crew realigned the lifeband and the platform performed compressions for 10 seconds and displayed same error message again before stopping.The crew stopped the platform and waited for 10 minutes before turning it back on.During the 10 minute pause the crew reverted to manual cpr, re-positioned the patient and re-aligned the bands on the platform.The platform performed compressions for 2 minutes before displaying the "re-align band" error message again.No known impact or consequence to patient information was available.

Manufacturer Narrative

The reported event of the autopulse platform (sn (b)(4) was confirmed through archive data review.The probable root cause was due to the autopulse platform did not reach the target depth within the specification time due to the stiffness of the patient chest.Upon visual inspection, no physical damage was observed.The platform failed initial functional testing due to ua12 (lifeband not present) error message, unrelated to the customer reported problem.Performed the lifeband clip detect switch inspection, and observed the two screws which hold the lever parallel to the switch case were loose.Adjusted the switch and torqued the two lock screws that holds the switch lever parallel to the switch case.Standard belt clip test was performed and the platform passed the test without any fault or error.The archive data review showed that the autopulse platform stopped performing compressions six times due to ua 17 (max motor on time exceeded) error message on the customer reported event date.Per archive, the autopulse li-ion battery (sn (b)(4) with 1462 mah remaining capacity was used.The autopulse platform performed 207 compressions on the medium size patient and then stopped performing compressions due to ua17 (max motor on time exceeded) error message.The user pressed restart to clear the fault.The autopulse platform was used again with the same battery and stopped performing compressions five more times due to ua17 within the time frame of 16 minutes.The probable root cause was due to the autopulse platform did not reach the target depth within specification time due to the stiffness of the patient chest.Following the 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.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.The 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 and when the battery being used has a low voltage.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8324076
• MDR Text Key: 136151223
• Report Number: 3010617000-2019-00074
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• 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: 02/05/2019
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR