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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse lifeband in complaint was returned to zoll on 10/26/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

The customer reported that during a shift check the autopulse lifeband would not retract completely.The customer checked and adjusted the lifeband, problem still persisted.No report of patient involvement.No further information was provided.

Manufacturer Narrative

The autopulse platform (b)(4) was returned to zoll on (b)(6) 2015.Investigation results as follows: a visual inspection of the returned autopulse platform was performed and found that the battery lock was bent.Additionally, one screw was missing from the load plate and bottom covers.Note this physical damage can occur due to normal wear and tear and/or physical abuse.A review of the platform archive was performed and there were several user advisory (ua) 45 (shaft not at "home" position) occurred on (b)(6) 2015 but not on the reported event date of (b)(6)2015.The archive data showed that the platform was not used on the reported event date.During functional testing, the autopulse platform displayed ua 45 upon power up and the lifeband did not retract.Further investigation showed that the drive shaft clutch plate was sticky.The drive shaft was rotated back to the "home " position to clear the advisory message.After drive shaft rotate to home position, the platform was run for 10 minutes using lrtf (equivalent to 250 pound patient) with no user advisories occurring.Based on the visual inspection, the drive shaft was cleaned to remedy the reported complaint.Additionally, the damaged battery lock and missing hardware for the load plate cover were replaced.In summary, the customer's reported complaint of lifeband was confirmed during functional testing and was attribute to a sticky drive shaft.After cleaning the drive shaft, the autopulse passed all the tests and meet all the required specification.Note that user advisory error messages are designed into the platform when one of several conditions is detected.Ua 45 alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruct, to clear ua 45, the operator needs to pull up the lifeband until the chest bands are full extended.This action will move the driveshaft to its home position.

• 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: 5192276
• MDR Text Key: 29985298
• Report Number: 3010617000-2015-00580
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• 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