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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

In reviewing the reported complaint on (b)(4), it was noted by the customer that the autopulse platform s/n (b)(4) was used on several patients and all the patients had expired, rosc were not achieved.According to the customer, a preventive maintenance service was never performed on this platform.Several attempts were made to gather additional information however were unsuccessful.No patient harm or consequences were reported.Reference mfr report # 3010617000-2017-00649 = (b)(4).

Manufacturer Narrative

The customer reported issue of stopped compression was confirmed in the archive review data however was not replicated during the functional testing.The root cause was due to the autopulse platform not reaching target depth on a medium sized patient chest that was stiff to compress and resulted in the autopulse exhibiting a ua17 (max motor on time exceeded during active operation) error message.Visual inspection was performed and found no physical damaged observed upon receipt.The archive review showed that on (b)(6) 2017, the autopulse performed 37 compressions for a duration of 30 seconds on a regular size patient however the platform stopped compressions due to ua07 (discrepancy between load 1 and load 2 too large ) error message.This indicated that the load sensing system has detected a weight/load imbalance between the two load cells.Ua07 indicated that either the patient not oriented on the autopulse platform correctly or the patient has shifted during compression.Archive showed that the user pressed restart to clear the ua7.Archive showed that the platform was used with the same battery with remained capacity of 1201mah and performed 7 compressions on a medium size patient and stiff to compress (the max load exceeded 209 lbs.) the platform showed battery remained capacity was 1194 mah and the autopulse was continued to use and stop 4 times due to ua17 (max motor on time exceeded during active operation) error message within a 10 seconds timeframe.User advisory 17 is an indication that the battery voltage is low.Functional testing was performed and the autopulse platform passed all the testing without any fault or error observed.The autopulse platform performed as intended.In addition, load cell characterization testing was performed and both of the load cells passed and are within the specifications.Run in test was also performed using the 95% patient large resuscitation test fixture (lrtf) and the returned lifeband with a known good test batteries until discharged without any fault or error.The autopulse passed successfully with no issues were observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.Based on available information, autopulse stopped after unknown length of compression.Manual cpr was then performed.Rosc was not achieved by the combination of mechanical and manual cpr.For a trained user, changing from the autopulse to manual cpr can be made quickly, and is similar to the time necessary for rescuer rotation, presenting the same workflow as high quality manual cpr.Because the conversion from mechanical to manual cpr were quick and available, the patients' outcome was not negatively impacted when compared to standard of care manual cpr.No information is provided on the patient's clinical condition.However, the cause of patient's death was likely to be patient's underlying clinical condition and bad prognosis.No information is available for the use of the autopulse on previous patients.It is not clear if any device issue was noticed during previous use.No information is available for the clinical conditions of previous patients.A relationship between the use of the autopulse device and the expiration of the previous patients cannot be established base on available information.Case will be reassessed when additional information is receive.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6787105
• MDR Text Key: 82866831
• Report Number: 3010617000-2017-00663
• 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
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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: 08/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2014
• 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