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

Model Number 8700-0701-03

Device Problem Positioning Failure (1158)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Event Description

It was reported during a device check, that the autopulse lifeband would not remain in place as a result of a loose connection.There was no report of any patient involvement.No additional details were provided.

Manufacturer Narrative

The autopulse lifeband in complaint was returned to zoll for investigation.Investigation results are as follows: visual inspection was performed and it appears that the returned lifeband had not been used.Investigation of the lifeband found that the hinge located on the left corner/channel brace assembly was bent and out of position.Functional evaluation was unable to performed given the condition of the unit received.In summary the customer's reported complaint that the lifeband would not remain in place as a result of a loose connection was confirmed.The hinge located on the left cover/channel brace assembly was bent out of position thus preventing the belt guards from locking in place.

• 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: 5168584
• MDR Text Key: 28945489
• Report Number: 3010617000-2015-00575
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065016
• UDI-Public: 00849111065016
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/28/2015

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: 8700-0701-03
• Device Catalogue Number: 8700-0701-03
• Device Lot Number: 12359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• 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