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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2015

Event Type  malfunction  

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.

Event Description

It was reported that during a morning shift check, the autopulse platform displayed a "system error" message.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 08/21/2015 for investigation.Visual inspection of the returned platform was performed and found that the front enclosure was damaged.The physical damage found during visual inspection is unrelated to the customer's reported complaint of the platform displaying a "system error" message.A review of the platform's archive data was performed and revealed that there were no sessions on the reported event date of (b)(6) 2015.However, the archive data indicated that a "system error code 132 - internal watchdog timeout" occurred on (b)(6) 2015, thus confirming the customer's reported complaint.The reported "system error" message was also replicated when the platform was powered on for functional testing.Functional testing could not be performed due to the observed "system error" message.Further investigation determined that the pca processor board was defective.Unrelated to the reported complaint, it was observed that the clutch plate was sticky and needed to be deburred.Based on the investigation, the parts identified for replacement were the pca processor board and the front enclosure.In summary, the customer's reported complaint of the platform displaying a "system error" message was confirmed through review of the platform's archive data and was also replicated when the platform was powered on for functional testing.The root cause was determined to be a defective pca processor board.Unrelated to the reported complaint, it was observed that the clutch plate was sticky and needed to be deburred.The physical damage found during visual inspection is also unrelated to the customer's reported complaint.After replacement of all the parts identified during investigation, the platform successfully passed all final functional testing.

• 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: 4993984
• MDR Text Key: 22638833
• Report Number: 3010617000-2015-00459
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2009
• 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