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

Model Number 8700-0701

Device Problems Loose or Intermittent Connection (1371); Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse lifeband retracted but then loosened.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse lifeband in complaint was returned to zoll on 12/02/2014 for investigation.Investigation results as follows: visual inspection was performed and no damages were observed to the lifeband.The lifeband was tested using the customer's returned autopulse platform (s/n (b)(4)) on a regular mannequin and a large resuscitation test fixture (lrtf) with no issues presented.The reported problem of the lifeband loosening was not observed.The returned unit was tested using the customer's autopulse platform (s/n (b)(4)) on both a regular mannequin and a large resuscitation test fixture for 1 hour each with no issues or advisories observed.Please note that the customer did not allege any deficiencies against the autopulse platform (s/n (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: 4362767
• MDR Text Key: 5292142
• Report Number: 3010617000-2014-00676
• Device Sequence Number: 1
• Product Code: DRM
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/01/2014

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
• Device Catalogue Number: 8700-0701
• Device Lot Number: 51414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2014
• 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