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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/05/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported to zoll (b)(4) that during patient use the autopulse platform (s/n (b)(4)) stopped after 10 minutes of compressions.The device was being used on a patient (approximately (b)(6)) down due to cardiac arrest after being involved in an industrial accident.The emts were the second responders and took over from the volunteer bls team.Emt stated that the patient had signs of electrical burns.The bls team was performing manual cpr when the emts arrived and while they were preparing the autopulse (ap) for use.The patient had been down less than 20 minutes.The ap started without issue and performed compressions for 10 minutes, then stopped.Manual cpr was started while the crew changed the battery on the ap.The ap started again without issue and performed compressions for another 10 minutes, at which time it stopped.The emts arrived at the hospital and transferred the patient's care to the er.The patient expired at the hospital.The emt crew arrived back at the station and changed the battery once again on the ap.They tested the ap with a mannequin, which it performed with no problems.The ap is checked daily by the crew and the batteries are charged and swapped out every 24 hours.None of the batteries showed any signs of failure.Related mfr 3010617000-2016-00107 (s/n (b)(4)).

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for investigation on 02/05/2016.Device history record (dhr) was reviewed and no previous related complaint was reported for this autopulse platform (s/n (b)(4)).Visual inspection of the returned platform was performed and no physical damages were noted upon receipt.A review of the archive was performed and based on the information reviewed (ua) user advisory 2 - compression tracking error occurred on the first compression.User advisory 17 - max motor on time exceeded, warning 1 - low battery warning, user advisory 19 - max applied load exceeded were also observed in the log.Functional testing was performed and device passed functional testing without any fault or error observed.In summary the customer's reported complaint was confirmed.Based on the platform's archive, on the date of event (b)(6) 2015 li-ion battery s/n (b)(4) with a high remain capacity of (1357) was used on a medium/large patient stiff to compress.After 26 cycles of compression, the device stopped compressions due to ua 2.This fault typically occurs when the patient is misaligned on the platform or the lifeband is opened.The device was then restarted and device stopped again in a few minutes later due to ua 17.The remain capacity of the battery dropped down to the level of low battery warning.On the same day, the device was used again eight hours later.A different li-ion battery s/n (b)(4) with a high remain capacity was inserted.The device was used to compress with a very large/stiff to compress object/patient.After a few compression, the device was stopped multiple times due to ua 19.A run_in testing was performed using the 95% patient test fixture (lrtf), the device failed after a few minutes due to system error 139 - unable to hold compression position.A drive train motor brake gap inspection was performed and the brake gap was confirmed to be out of the specification.The drive train motor was replaced in order to continue with other tests.The root cause of the reported complaint is related to the drive train motor brake gap being out of tolerance causing the brake to disengage.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5460763
• MDR Text Key: 39039989
• Report Number: 3010617000-2016-00106
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• 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?: Yes
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2014
• 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