MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR,

Model Number MODEL 100

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

It was reported that during patient use, the autopulse® platform performed one compression and then stopped.It is unknown if manual cpr was performed.Information regarding the patient was not provided, however no adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Customer also reported that the two batteries used during this event were nimh with serial numbers (b)(4).19 test cycles were performed with nimh battery s/n (b)(4) and 5 test cycles were performed with battery (b)(4).Customer also indicated that proper battery management is being performed.Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

Since the call the batteries have been replaced with the li-ion batteries.The charger has also been replaced.At this point the customer will not be sending in the autopulse for further evaluation.

Event Description

After an internal investigation was conducted, the customer believes that during the call the lifeband was twisted on the right side.The customer was able to recover the lifeband that was used on the patient and it was observed that there was a pronounced crease on the side of the lifeband that is close to the autopulse.The crease was approximately 8 inches from the thicker compression pad.The customer believes that the lifeband jammed, which resulted in the autopulse stopping compressions.One of the emt's involved in this case indicated that the patient was rocking to one side, which provided an indication that only one side was working.The autopulse was on the entire time, however no compressions were being performed.The crew discontinued use of the autopulse and reverted to manual cpr (exact length of time was not provided).No further details were provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR,
• 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: 4561215
• MDR Text Key: 5475261
• Report Number: 3010617000-2015-00132
• Device Sequence Number: 1
• Product Code: DRM
• 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: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1