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

Model Number MODEL 100

Device Problems Loss of Power (1475); Failure to Power Up (1476); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 11/13/2014

Event Type  malfunction  

Event Description

Complainant alleged that during use, the autopulse platform unintentionally shuts down and will not power back up.However, when it does power up, the battery indicator shows that it is empty even though the battery is fully charged.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

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

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection was performed and the front enclosure was found to be damaged.Based on the condition of the returned platform, the damage appears to have been due to wear and tear.Functional testing with a large resuscitation test fixture (equivalent to 250lb patient) was performed for approximately 25 minutes with no problems found.The reported complaint of the platform powering off during use could not be duplicated during testing.A review of the archive was performed and no user advisories occurred on the reported event date of (b)(6) 2014.However, consistent with the reported event, multiple user advisory 3 codes (error communicating with battery controller) were observed on (b)(6) 2014.Based on the archive date, the reported complaint is confirmed.Further inspection of the device did not identify any mechanical issues which could have caused or contributed to the observed ua 3 codes.Subsequently, a cause could not be determined.A review for battery management determined that the batteries used with this platform are being maintained properly.Based on the investigation, the part identified for replacement was the front enclosure.The reported complaint was confirmed based on archive review which indicated that multiple ua 3 codes occurred on (b)(6) 2014.A cause for the ua 3 codes could not be determined based on evaluation of the device.The platform passed all functional testing performed.Following service, including replacement of the damaged front enclosure, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4318971
• MDR Text Key: 5248859
• Report Number: 3010617000-2014-00652
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• 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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2011
• 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