MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number 8700-0701-01

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) 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 mylar 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 lifeband in complaint was returned to zoll on 10/24/2014 for investigation.Investigation results as follows: 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.However, the root cause for the damaged lifeband is unknown.Please see the following related mfr.Report #3010617000-2014-00591 for autopulse® resuscitation model 100 with serial number: (b)(4).

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• 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: 4238587
• MDR Text Key: 4974218
• Report Number: 3010617000-2014-00592
• 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: 8700-0701-01
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: 49709
• 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
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MANUAL CPR
• Patient Age: 81 YR