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

Model Number 8700-0701-03

Device Problems Positioning Failure (1158); Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2015

Event Type  malfunction  

Event Description

It was found by the customer during device check that the lifeband was unable to be installed into the auto pulse platform.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Zoll (b)(4) confirmed the customer's reported complaint and found that the lifeband had a plastic burr near the buckle which can interfere with installation.Zoll (b)(4) sent the lifeband to (b)(4) for further investigation.However, zoll (b)(4) has not yet received the lifeband.A supplemental report will be filed when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse lifeband (lot # 52725) was returned to zoll (b)(4) for evaluation.Investigation results are as follows: visual inspection of the returned autopulse lifeband confirmed the customer's reported issue.Additional material at one of the cover plate's flanges was observed.Functional testing was performed and the returned lifeband was tested with a test autopulse platform and the customer's reported issue was confirmed.The additional material at the cover plate's flange prevented the cover plate from completely clipping onto the autopulse platform cover.No other issues or discrepancies were observed.In summary, the customer's reported complaint that the lifeband was unable to be installed into the autopulse platform was confirmed and is attributed to the presence of additional material at one of the cover plate's flanges.

• 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: 4721644
• MDR Text Key: 5743485
• Report Number: 3010617000-2015-00246
• Device Sequence Number: 1
• Product Code: DRM
• 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,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/31/2015

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: 52725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/22/2015
• 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