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

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

It was reported that the autopulse platform was used on a patient who was very small and frail.Patient had an extensive medical history (specific details were not provided).The medic stated that the patient was unresponsive for 25 minutes prior to the application of the autopulse.The patient was properly positioned on the platform.The autopulse lifeband was positioned at the patient's armpit line and the chest straps were secured.The medic stated that during cpr by all agencies, rib cracking was often heard, especially at the start.At least 6 minutes of manual cpr was performed prior to the autopulse.The medic reported that when the autopulse was removed, the patient had what appeared to be a "slight punched rib" on the right side where the lifeband coiled.The reported "slight punched rib" appeared to puncture through the patient and then went back in.The medic stated that a fracture could not be positively ruled in or out.There was a small puncture wound with blood around it (no oozing).The appearance of bruising was not obvious at that time from what the medic could remember, just whitening to the area and some swelling.The medic did not know which rib was "punched" but guessed that it was between 5 and 7.The medic indicated that the patient was in active vomiting and choking during the entire call and that airway clearing was the priority.Patient subsequently expired; however, patient's death was not related to the autopulse.It is unknown if the reported "punched rib" was due to the autopulse.There were no reports of a device malfunction.No further information was provided.Please note that the date of event was not provided by the customer.Manufacturer has requested additional information from the customer; however, no additional information has been obtained.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/10/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection was performed and no damages were observed to the platform.The platform ran with a large resuscitation test fixture with no faults or errors occurring.The device performed as intended during functional evaluation.Load cell characterization was also performed and both load cell modules were confirmed to be functioning within specification.A brake gap inspection was also performed which verified that the brake gap was within the specification of 0.008" ±0.001".Based on the functional evaluation, there were no issues identified with the platform that indicates the device caused or contributed to the reported patient injury.Based on the platform's archive, it appears the platform was used to perform compressions on the patient on (b)(6) 2015.The archive shows that there were multiple user advisory (ua) 2 (compression tracking error), ua 12 (lifeband not present), ua 16 (timeout moving to take-up position), and ua 18 (max take-up revolutions exceeded) codes on this date.There were no device deficiencies identified during inspection of the platform that may have caused or contributed to the observed codes.The ua 2 and ua 16 codes likely occurred as a result of the patient being misaligned on the platform.The ua 12 codes occurred because the belt clip of the lifeband was not detected in the platform's spool shaft, which was likely due to improper installation or removal of the lifeband.Based on the information provided, the ua 18 codes likely occurred as a result of the patient's chest size being too small.The review of the archive data showed that the load, pressure and displacement provided by the autopulse platform during patient use, were all well below levels that could cause or contribute to injury to a patient.Based on the investigation, no parts were identified as needing replacement.In summary, the autopulse was functionally tested and the device performed as intended during functional evaluation.Load cell characterization was also performed and both load cell modules were confirmed to be functioning within specification.A brake gap inspection was also performed which verified that the brake gap was within the specification of 0.008" ±0.001".There were no issues identified with the platform during functional evaluation that indicates the device caused or contributed to the reported patient injury.Furthermore, the platform's data archive was reviewed which showed that the load, pressure and displacement provided by the autopulse platform during patient use, were all below levels that could cause or contribute to injury to a patient.The archive data does not indicate that there is a causal relationship between the reported injuries and the autopulse platform.

• 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: 4547719
• MDR Text Key: 5511027
• Report Number: 3010617000-2015-00117
• 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: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 02/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2009
• 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 Outcome(s): Other