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

Model Number MODEL 100

Device Problems Positioning Failure (1158); No Display/Image (1183); Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Event Description

It was reported that the leds on the user control panel of the autopulse platform were illuminated, when the device was powered on.However, the prompts on the lcd display were not visible.When the battery status check button was pressed on the battery that was used with this platform; the light emitting diodes illuminated, thereby providing an indication that the battery was ready for use.A training lifeband was installed.There was no report of any patient involvement.No additional details were provided.

Manufacturer Narrative

This supplemental is being submitted for mfr 3010617000-2015-00519, which is a duplicate of mfr 3010617000-2015-00553 that was submitted on 12/21/2015.The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) on 12/03/2015.Investigation results as follows: a visual inspection of the returned autopulse platform was performed and the short black cover was observed to be damaged.Visual inspection of the internal device showed no damages.A review of the archive was performed and no discrepancies were observed.The platform was functional tested and the autopulse the reported complaint of the device does not turn on was confirmed.Further investigation indicated that the processor board and the cable from the load cell amplifier to the processor board were defective.Replacing the parts remedied the ua7.The platform passed the load cell characterization test.Based on the visual inspection, the short black cover was replaced.Additionally, the power distribution board was also replaced to remedy the reported complaint.In summary, the customer's reported complaint of the platform not turning on and not leds illuminating was confirmed during functional testing.After replacement of the part identified during investigation, the platform passed all final functional 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: 5114226
• MDR Text Key: 27145166
• Report Number: 3010617000-2015-00519
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• 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: 12/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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