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

Model Number MODEL 100

Device Problem Battery Problem (2885)

Patient Problems Cardiac Arrest (1762); Death (1802); Electric Shock (2554)

Event Date 12/20/2014

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2014, the ems received a call for a patient in cardiac arrest, post electrocution.An aed was applied on scene prior to ems arrival but no shocks were advised.Upon arrival, the ems crew placed the patient on the autopulse platform.The platform performed compressions for approximately 5 minutes using an autopulse li-ion battery with an unknown serial number (sn).When this initial battery depleted, the crew replaced the battery with another li-ion battery (sn (b)(4)).However, the platform did not perform any compressions with this second battery.The patient reportedly expired.No further information was provided.Manufacturer has requested additional information from the customer.However, no additional information has been obtained.

Manufacturer Narrative

Customer stated that after the call, the second battery (sn: 07131) was brought back to the base and put into an autopulse multi-chemistry charger (mcc).The mcc status led initially illuminated yellow indicating that the battery was charging.However, the status led changed to red, which indicated that the battery had been disabled by the charger.In addition, when the battery's status check button was pressed, one red bar illuminated indicating that the battery should not be used.Customer is on a 3 battery rotation with batteries rotated once a week, even if not used.Customer also stated that batteries are changed after use.Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Please see the following related mfr.Reports: 1.#3010617000-2015-00156 for autopulse® li-ion battery with sn: (b)(4).2.#3010617000-2015-00157 for autopulse® li-ion battery with sn: unknown.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 05/01/2015 for investigation.It should be noted that the two autopulse li-ion batteries (sn: (b)(4) and unknown) used in the reported complaint was not returned for evaluation.Visual inspection of the platform was performed and no damages were observed.Functional testing was performed and the reported complaint of the platform stopping compressions after the reported short durations (5 and 10 minutes) could not be duplicated.Compression testing was performed with a large resuscitation test fixture for 50 minutes without stoppages until a user advisory (ua) 41 (patient temperature sensor failure) was observed.The ua 41 is considered unrelated to the reported complaint.Further inspection identified the cause of the ua 41 to be a defective patient temperature sensor.Following replacement of the sensor, the platform ran for an additional hour, with no other user advisories, system errors or warnings exhibited.Load cell characterization was performed which showed that both load cell modules were functioning within the specification.A brake gap inspection was also performed which verified that the brake gap was within the specification of 0.008" ±0.001".The platform's archive data was extracted; however, it was found to be partially corrupted.The archive did not show any data on or around the reported event date of (b)(6) 2014.The reported event could not be confirmed based on review of the archive.A review of the partially extracted archive was performed and no issues related to improper battery management were observed.Based on the data available, the customer is properly managing batteries used with this platform.Based on the investigation, the part identified for replacement was the patient temperature sensor.In summary, the reported complaint of the platform stopping compressions after a short duration could not be duplicated.The platform ran continuously for 50 minutes during functional testing, prior to exhibiting a ua 41 code, which was deemed unrelated to the reported event.The patient temperature sensor was replaced to remedy the ua 41.The platform then ran continuously for an additional hour, with no issues observed.There were no device deficiencies observed during testing which could have caused or contributed to the reported event.Load cell characterization was performed, which showed that both of the load cells were functioning within specification.A brake gap inspection was also performed, which verified that the brake gap was within specification.Following service, including replacement of the patient temperature sensor, the device passed all testing criteria.

• 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: 4625089
• MDR Text Key: 5588998
• Report Number: 3010617000-2015-00155
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• 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: 8700-0700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2004
• 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