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 Problem Injury (2348)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) in complaint was returned to zoll for investigation on 06/08/2016.A dhr review for s/n (b)(4) found no previous complaints related to this event.During the visual inspection, it was observed that the front cover was cracked.The archive data results showed a user advisory 18 (max take-up revolutions exceeded), user advisory 17 (max motor on time exceeded), user advisory 2 (compression tracking error) which occurred on the first compression and user advisory 12 (lifeband not present) also occurred.In summary, based on the platform's archive data, on (b)(6) 2016, the li-ion battery s/n (b)(4) showed it had a remaining capacity (rc) equivalent of about three green led's (three bars on autopulse display).The autopulse performed 570 compressions over a period of about six minutes and fifteen seconds on a regular size patient.At which time the autopulse stopped compressing due to user advisory (ua) 17 (max motor on time exceeded).At this time, the remaining capacity of the battery dropped.The user re-started the autopulse, which cleared the ua 17 fault and continue compressions on the patient.After delivering 194 compressions, for two minutes and twenty nine seconds, the device stopped again due to user advisory 2 (compression tracking error).This ua fault may have been caused by movement of the patient or autopulse.Once again the user re-started the autopulse which cleared the ua 2 fault and the device continue to be used until it stopped two additional times due to a low battery warning (the same battery was still in use) and user advisory 4 (battery charge state too low).No further uas or faults were recorded in the archive log until the device was received and tested by zoll.The front cover was replaced.A load cell characterization test confirmed both load cell modules were functioning within specification.A drive train motor brake gap inspection was performed and verified it was within specification.The autopulse has passed all the testing criteria and meets all required specifications.Please note that the user advisories found during the archive data review were unrelated to the reported complaint of possible rib fractures.Also the user advisories found would not have caused a device deficiency that would have resulted in rib fractures.

Event Description

It was reported that after patient use with the autopulse platform (s/n (b)(4)), "fluid" was believed to be inside the patient's chest cavity.The user indicated this could be due to a broken rib/pneumothorax.The user also reported that there was no "fluid" seen on the autopulse platform.No other patient information was provided.Numerous attempts were made for additional information regarding this event, however the attempts have been unsuccessful.No other information was provided on whether manual cpr was administered prior to use of the autopulse.There was no report of a device malfunction.

• 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: 5749446
• MDR Text Key: 48192240
• Report Number: 3010617000-2016-00429
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/24/2016

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2009
• 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
• Patient Outcome(s): Other