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

Model Number MODEL 100

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2014

Event Type  malfunction  

Event Description

It was reported that during use on an (b)(6) year old male, cardiac arrest patient, weighing less than 300 pounds, the autopulse lifeband snapped during compressions.It is unknown how long the autopulse platform was performing compressions for before the lifeband snapped.The lifeband snapped at the part where the chest band at the end of the lifeband cover plate (grey part) connects to the chest band strap (white meyler material).The crew reverted to manual cpr (exact length of time was not provided) when the lifeband broke.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform and lifeband in complaint were returned to zoll on 10/24/2014 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found that the front enclosure was damaged.The physical damage found during visual inspection of the platform is not related to the reported complaint that the lifeband snapped at the part where the band connects to the strap (i.E.Where the gray meets the white).The physical damage observed during visual inspection appears to have been caused by normal wear and tear (autopulse manufactured in january of 2011).Visual inspection of the returned lifeband shows that it was damaged.The lifeband was snapped between the gray part of the lifeband at the end of the cover plate where the band meets the strap.The physical damage found during visual inspection of the lifeband confirmed the reported complaint.The root cause for the damaged lifeband is unknown.A review of the autopulse platform's archive was performed and the reported complaint was confirmed.The archive data shows that user advisory (ua) 2 (compression tracking error) occurred on the first compression as well as ua 20 (position out of range (no wind)) faults on (b)(6) 2014, rather than on the reported event date of (b)(6) 2014.A ua 2 typically occurs if the patient is misaligned on the platform or if the lifeband is opened.Functional testing of the returned platform was performed and the reported complaint was not confirmed.The platform ran for 7 minutes using a test mannequin and 30 minutes using a large resuscitation test fixture (lrtf), equivalent to a 250 pound patient, and no problems were observed.Based on the initial investigation, the part identified for replacement was the front enclosure.In summary, the reported complaint that the lifeband snapped at the part where the chest band at the end of the lifeband cover plate (grey part) connects to the chest band strap (white meyler material) was confirmed based on the platform's archive review and during visual inspection of the lifeband.Visual inspection found that the lifeband was damaged.However, a root cause for the damaged lifeband is unknown.The observed ua 2 fault occurred because the lifeband snapped, which caused it to break and resulted in the lifeband being opened.The root cause for the ua 20 fault is unknown.Please see the following related mfr.Report #3010617000-2014-00592 for autopulse® lifeband with lot #: 49709.

• 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: 4238447
• MDR Text Key: 16859698
• Report Number: 3010617000-2014-00591
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2011
• 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
• Treatment: MANUAL CPR
• Patient Age: 81 YR