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

Model Number 8700-0701

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse lifeband in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

During the inspection in the (b)(6) warehouse, an operator noticed that there was no plastic brace attached to one side of a lifeband.No patient involvement was reported.

Manufacturer Narrative

The autopulse lifeband (s/n (b)(4)) was returned to zoll (b)(4) for evaluation.A visual inspection of the returned lifebands was performed and found that there was no plastic brace attached to one side of lifeband skirt on one lifeband.No other issues were observed.Other two lifebands had no issues.Evaluation of the returned autopulse life band confirmed the customer reported issue.The root cause for reported issue is related to supplier's inspection process.A supplier corrective action request (scar) was initiated.Corrective action was initiated by supplier to prevent recurrence.

• 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: 5679736
• MDR Text Key: 45980303
• Report Number: 3010617000-2016-00362
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

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: Other
• Device Model Number: 8700-0701
• Device Catalogue Number: 8700-0701-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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