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

Model Number MODEL 100

Device Problem Loss of Power (1475)

Patient Problems Cardiac Arrest (1762); Death (1802); Vomiting (2144)

Event Date 08/10/2014

Event Type  malfunction  

Event Description

It was reported that an initial call came into (b)(6) fire department on (b)(6) 2014 for an unresponsive (b)(6) male patient, weighing approximately (b)(6) lbs.The cardiac arrest occurred at the patient's residence and it was unwitnessed.Patient had no complaints prior to the arrest.It is unknown how long the patient was down prior to responding agency's arrival.Bystander cpr was not performed.Manual cpr was performed for a few minutes by (b)(6) police department.(b)(6) fire department took over and continued manual cpr, however, exact duration is unknown.The autopulse platform was deployed without any issues.The platform performed compressions for a total of 12 minutes and then stopped and powered off.No error messages were observed.The autopulse li-ion battery was replaced and compressions were restarted without any issues.Manual cpr was performed while the battery was being exchanged.Direct video laryngoscopy was performed as there were some difficulties intubating due to the presence of blood and vomit in the patient's airways.Four rounds of epinephrine were also administered.The autopulse platform performed compressions for another 3-4 minutes before the patient was pronounced dead by the (b)(6) fire department.There were no issues with the platform after the crew replaced the battery.Patient never achieved rosc (return of spontaneous circulation).The cause of death is unknown.However, the customer indicated that the patient had a history of copd (chronic obstructive pulmonary disease) and stroke.Customer does not attribute the patient's death to the use of the autopulse.It is unknown if an autopsy was performed.No further information was provided.

Manufacturer Narrative

Please see the following related mfr.Report #: 3010617000-2014-00455 autopulse li-ion battery with sn: (b)(4).Zoll circulation has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) and li-ion battery (s/n (b)(4)) were returned to the manufacturer for evaluation.Visual inspection of the returned platform was performed and no damage was observed.The returned platform underwent and passed initial functional testing.The system was turned on/off and no problems, anomalies or errors were exhibited.A review of the archive was performed which showed that no sessions occurred on the reported event date of (b)(6) 2014.However, on (b)(6) 2014 the platform exhibited a warning 1 (low battery warning), ua17 (max motor on time exceeded) and ua2 (compression tracking error) messages.Review of the archive also shows that the customer first turned the platform on using battery (s/n (b)(4)).Battery (s/n (b)(4)) was placed into the platform on (b)(6) 2014, without being removed or charged prior to use on (b)(6) 2014.The platform ran for 9:39 minutes before exhibiting the first warning 1 message followed by a user advisory (ua) 17.The customer then replaced battery (s/n (b)(4)) with battery (s/n (b)(4)) which performed as intended for approximately 37-45 minutes.Warning 1 is built into the autopulse to advise customer that the battery is close to being depleted and needs to be exchanged.Per the autopulse maintenance guide (p/n 11653-001) ua17 typically occurs when the lifeband is twisted, or the battery voltage is low.The root cause of the ua17 was determined to be the customer using a low voltage battery (s/n (b)(4)).Per the autopulse maintenance guide (p/n 11653-001) ua2 occurs when the autopulse has detected a change in life-band tension.As no issues were identified during functional testing associated with a ua2, a probable root cause of the platform exhibiting a ua2 was determined to be due to a change in the life-band tension.The autopulse platform was designed to exhibit a ua2 in order to prevent patient harm due to changes in life-band tension.A review of the archive was performed to assess the customer's battery management practices.Review of the archive shows that the customer is not properly maintaining their batteries.It also shows that daily system checks are not being performed as recommended per the ifu.No parts were replaced on the platform related to the customer reported complaint.The platform underwent and met all final functional testing criteria.The customer's reported complaint was confirmed through review of the archive.The root cause of the low run time was caused by the customer not using a fully charged battery during autopulse platform operation.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4060240
• MDR Text Key: 4908999
• Report Number: 3010617000-2014-00454
• Device Sequence Number: 1
• Product Code: DRM
• 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: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• 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: 09/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2013
• 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
• Treatment: MANUAL CPR
• Patient Age: 81 YR
• Patient Weight: 82