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 Laceration(s) (1946); Injury (2348)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

The autopulse platform in complaint will not be returned for investigation.Therefore a physical investigation will not be performed.There were no device deficiencies reported by the customer.The autopulse platform performed as intended for 2.5 hours without any device failures.Additionally note that prior to the incident the customer performed their normal daily inspection of the autopulse device.No irregularities found during the inspection.Based on the information received from the customer, rosc was not achieved even after 2.5 hours of successful autopulse compressions.There were no device malfunctions experienced.The autopulse did not contribute to patient death.Abrasions on the patient chest were probably related to autopulse usage.However the patients shape and band positioning may have been contributing factors.Additionally, the platform was used for a prolonged resuscitation.Note - the autopulse user guides provides guidance stating that operating the autopulse on a patient for extended periods of time may result in minor skin irritation to the patient.Failure to properly position a patient, both vertically and laterally with respect to the autopulse platform, may cause injury to the patient.

Event Description

The customer reported that during an elective procedure in the catheter lab the patient arrested with a prolonged resuscitation of 2.5 hours.Due to the extended resuscitation the patient suffered injuries from the lifeband sliding up to the patient's axilla and up to the pectorals on both sides.The resuscitation with the autopulse platform (s/n (b)(4)) was unsuccessful and the patient expired in the cath lab.The patient was undergoing an interventional procedure for calcific coronary artery disease including rotablation.The patient became hemodynamically compromised early on in the procedure requiring intra-aortic balloon pump (iabp) and temporary pacing to maintain blood pressure.The decision was made to intubate and ventilate the patient but patient was profoundly shocked due to vt/vf.Full advance life support including autopulse was put into action to allow procedure to continue in an attempt to resuscitate the patient.Patient died in cath lab.The issue of the contusions was related to autopulse however the patients shape and band positioning may have been contributing factors as this was a very prolonged resuscitation.One hour after the resuscitation began and during a battery change, lacerations to the left side were observed.The right side lacerations were seen at the end of the procedure.Attempts were made to pad the area in an attempt to protect it.The patient appeared to have a short chest and a protruding abdomen, which pushed the lifeband upwards.There were no issues with the performance of the autopulse platform.The autopulse performed as intended.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) in complaint was returned to zoll on 03/24/2016 for investigation: investigation is as follows: device history record (dhr) was reviewed and no related complaints were found for this autopulse platform (s/n (b)(4)).Visual inspection was performed and found no physical damage to the enclosure.A review of the archive data showed user advisories (ua), unrelated to the reported complaint (event date of (b)(6) 2015).The uas found occurred between (b)(6) 2015 and (b)(6) 2016, are as follows: ua 19 (max applied load exceeded), ua 2 (compression tracking) errors occurred on the first compression, ua 18 (max take-up revolutions exceeded), ua 45 (shaft not at "home" position), ua 12 (lifeband not present).The device passed functional tests without any fault or error report.In summary, a review of the autopulse archive was performed and found many user advisories which were unrelated to the reported complaint and did not occur on the date of the event (b)(6) 2015.The uas found, indicated that the autopulse platform was used after the reported event date of (b)(6) 2015.The reported complaint was not due to a device malfunction, therefore based on the investigation, the complaint is unconfirmed.The autopulse platform passed all final functional testing.

• 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: 5432683
• MDR Text Key: 38078788
• Report Number: 3010617000-2016-00065
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/15/2016

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2011
• 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
• Patient Outcome(s): Other
• Patient Weight: 75