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

Model Number 8700-0706-01

Device Problems Positioning Failure (1158); Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2015

Event Type  malfunction  

Event Description

It was reported that a cardiac arrest patient who had pulseless electrical activity (pea) was taken to the cardiac catheter lab, where a consultant requested the use of an autopulse platform.When placing the autopulse platform underneath the patient, it was observed that the large black clip on the lifeband became loose.Further inspection of the lifeband determined that one of the belt guards (black u-shaped plastic clips) on the sides of the lifeband did not "click" and snap into position on the metal post of the lifeband.The lifeband was subsequently removed from the autopulse platform.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse lifeband (lot # 54384) was returned to the manufacturer for evaluation.Visual inspection of the returned autopulse lifeband was performed and found that the locking tab was bent or warped outwards.There was no audible snapping sound when the hinged belt guard (referred to as the "side clip") was closed and opened.Therefore confirming the customer's reported complaint.Functional testing was performed and the returned autopulse lifeband was tested with a platform and no problems related to the customer's reported complaint were observed.Based on the investigation results, the probable cause for the damaged belt guard locking tabs is due to mishandling, possibly as a result of the lifeband being dropped, smashed or due to abnormal compressions while the belt guards were folded in.

Event Description

Additional information was received from the customer: the incident occurred during an emergency scenario and time was limited, therefore it is uncertain why the lifeband became loose.After the incident occurred, it was observed that the hinged belt guard did not appear to be functioning properly and that the hinged belt guard on one side was loose.The 'clicking' mechanism at the point of the hinge did not work.There was no issue with the second lifeband.

• 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: 4876493
• MDR Text Key: 5864268
• Report Number: 3010617000-2015-00364
• Device Sequence Number: 1
• Product Code: DRM
• 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,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0706-01
• Device Catalogue Number: 8700-0706-01
• Device Lot Number: 54384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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